News from the Heart Rhythm SocietyHRS/EHRA Expert Consensus on the Monitoring of Cardiovascular Implantable Electronic Devices (CIEDs): Description of Techniques, Indications, Personnel, Frequency and Ethical Considerations: Developed in partnership with the Heart Rhythm Society (HRS) and the European Heart Rhythm Association (EHRA); and in collaboration with the American College of Cardiology (ACC), the American Heart Association (AHA), the European Society of Cardiology (ESC), the Heart Failure Association of ESC (HFA), and the Heart Failure Society of America (HFSA). Endorsed by the Heart Rhythm Society, the European Heart Rhythm Association (a registered branch of the ESC), the American College of Cardiology, the American Heart Association
Section snippets
Preamble
This document represents expert consensus concerning the Monitoring of Cardiovascular Implantable Electronic Devices (CIEDs). The views expressed are of the international writing group consisting of seven cardiac electrophysiologists representing the Heart Rhythm Society (HRS), six from the European Heart Rhythm Association (EHRA) as well as one heart failure specialist representing the Heart Failure Society of America and another from the Heart Failure Association of the European Society of
Table of Contents
INTRODUCTION......908
DEFINITIONS......908
SECTION 1: Description of CIED Technology......909
SECTION 2: Indications, Paradigms, Frequency and
Content of CIED Follow-up......910
SECTION 3: Data Management Considerations......913
SECTION 4: Responsibilities and Roles of Personnel......915
SECTION 5: Ethical Considerations......919
SECTION 6: Reimbursement Considerations......921
CONCLUSIONS......922
APPENDICES......922
REFERENCES......924
Cardiovascular Implantable Electronic Device (CIED)
Cardiovascular implantable electronic devices include the pacemaker (PM), implantable cardioverter-defibrillator (ICD), cardiac resynchronization device (CRT), implantable loop recorder (ILR) and implantable cardiovascular monitor (ICM). Pacemakers, ICD and CRT devices have been described in detail and all of these devices collectively have been termed cardiovascular implantable electronic devices (CIEDs).,2, 3
Clinically Employed Allied Professional (CEAP)
The diverse group of nurses, physician assistants, technologists, technicians, and
Section 1: Description of CIED Technology
CIEDs have numerous programmable features and can also store substantial amounts of diagnostic information related to device function, arrhythmia frequency, cardiovascular hemodynamic parameters including transthoracic impedance and patient activity. Bidirectional telemetry using encoded and encrypted radiofrequency signals allows transmission of information to the CIED from the programmer and from the programmer to the CIED. This process permits review of the programmed parameters and stored
Section 2: Indications, Paradigms, Frequency and Content of CIED Follow-up
A variety of follow-up paradigms exist, although the previously published guidelines are no longer accurate and primarily refer to pacemaker follow-up based on earlier generations of implantable devices. The ideal follow-up paradigm will be determined for the individual patient by the follow-up clinic physician(s) and CEAPs. Factors that will influence the follow-up paradigm might include patient preferences, the patient's underlying medical condition, CIED-related issues, geographic isolation
Section 3: Data Management Considerations
In the era of electronic data storage and Internet-based data transmission, data safety and confidentiality issues have become paramount concerns. There are no uniform worldwide regulations governing manufacturer tracking or record-keeping requirements. In the United States, there is a legal requirement for registration and tracking of clinical devices, including CIEDs (Safe Medical Devices Act of 199020; amended by the FDA Modernization Act of 1997). In Europe there is only a requirement for
Section 4: Responsibilities and Roles of Personnel
It is important to realize that all parties involved in CIED monitoring must be responsible for specific aspects of the process in order to achieve optimal success from monitoring. Parties that have specific responsibilities include the patient, caregivers (which includes the referring physician and the physician and authorized CEAP that do the actual monitoring), the device manufacturer and regulatory agencies.
Prior to implantation of any CIED that must be monitored and/or is capable of
CIED Management in Dying Patients
Medical decisions near the end of life, the autonomy of dying patients under medical care, and the withholding or withdrawal of life-prolonging medical treatments34, 35, 36 are widely discussed in both the medical and nonmedical communities. There is limited literature that focuses specifically on CIEDs and associated issues arising in terminally ill patients. There is not an established set of guidelines.37, 38, 39, 40, 41, 42 This section was written to aid practitioners in making decisions
Section 6: Reimbursement Considerations
The implication of this document describing the purpose, process, personnel, equipment and techniques required for device follow-up is that the human and financial resources are available to accomplish the task. Unfortunately the implantation of the device has been the focal point of reimbursement and the ongoing application of the therapy has received much less attention. In North America there is a system that provides some reimbursement for the time, equipment and personnel involved in
Conclusions
Intrinsic to the implantation of a CIED is the care of the patient and device after implantation. The purpose of the device is not implantation but ongoing therapy. However the therapy requires monitoring and adjustments, which implies the availability of resources, including space, equipment and personnel. With the goal of increasing the length and quality of the patient's life, appropriate monitoring of device therapy has the ability to enhance the likelihood that the patient can pursue
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Address reprint requests and correspondence: Donna M. Goldberg, MPH, c/o Heart Rhythm Society, Suite 500, 1400 K Street, NW, Washington DC 20005. E-mail address: [email protected].