Estimate and reporting of longevity for cardiac implantable electronic devices: a proposal for standardized criteria

ABSTRACT

Background

Cardiac implantable electronic devices (CIEDs) are widely used according to consensus guidelines in various patient categories. The longevity of CIED is a major determinant of the frequency with which patients require device replacement. Given the mismatch between the useful life of the devices and patient survival, device replacement is often needed. There is a great variability in the criteria used by manufacturers to determine the longevity of pacemakers (PM), implantable defibrillators (ICDs), and devices for cardiac resynchronization therapy (CRT). Thus, a fair comparison and an effective device evaluation is often difficult.

Methods

The objective of this paper is to provide standardized criteria based on typical clinical settings for estimating the longevity of single and dual chamber ICDs, cardiac resynchronization defibrillators (CRT-D), single and dual chamber PMs, and cardiac resynchronization PMs (CRT- P) to be used in health technology assessment for an appropriate comparison among different devices.

Results

The proposed parameters, if applied to the current marketed devices, provide longevity values in the range 5–17.2 years.

Conclusion

The values of longevity with the non-standardized criteria used by the manufacturers result in higher maximum values respect to the proposed standardized criteria for CRT-D, CRTD-MPP, CRT-P, and Dual-chamber PM.

KEYWORDS:

• Cardiac implantable electronic device
• implantable cardioverter-defibrillators
• longevity
• pacemaker
• standardized criteria
• programming
• remote monitoring

Declaration of interest

M Landolina has received lecture fees from Boston Scientific, LivaNova, & Medtronic. G Boriani has received speakers’ fees from Boston and Medtronic. The authors have no other relevant affiliations or financial involvement with any organization or entity with a financial interest in or financial conflict with the subject matter or materials discussed in the manuscript apart from those disclosed.

Reviewer disclosures

Peer reviewers on this manuscript have no relevant financial or other relationships to disclose.

Additional information

Funding

This paper was not funded.