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Published on: February 28, 2012
Estimate and reporting of longevity for cardiac implantable electronic devices: a proposal for standardized criteria
Federica Censi1, Giovanni Calcagnini1, Eugenio Mattei1
1Department of Cardiovascular, Endocrine-Metabolic Diseases and Aging, Italian National Institute of Health, Rome, Italy.
Insights
Standardized criteria for cardiac implantable electronic devices (CIEDs) estimate longevity from 5-17.2 years. This provides fair comparison, unlike variable manufacturer criteria for pacemakers (PMs) and defibrillators (ICDs).
Area of Science:
- Cardiology
- Biomedical Engineering
- Health Technology Assessment
Background:
- Cardiac implantable electronic devices (CIEDs) are crucial for various patient groups, with device longevity impacting replacement frequency.
- Current manufacturer criteria for CIED longevity (pacemakers, ICDs, CRT devices) lack standardization, hindering device comparison and evaluation.
- The mismatch between CIED useful life and patient survival necessitates accurate longevity estimations for effective management.
Purpose of the Study:
- To establish standardized criteria for estimating CIED longevity in typical clinical settings.
- To enable fair comparison and effective evaluation of different CIEDs, including pacemakers, ICDs, and CRT devices.
- To support health technology assessment with reliable device longevity data.
Main Methods:
- Development of standardized criteria based on typical clinical settings.
- Application of these criteria to estimate longevity for various CIEDs: single/dual chamber ICDs, CRT-Ds, single/dual chamber PMs, and CRT-Ps.
- Comparison of longevity estimates derived from standardized criteria versus manufacturer-specific criteria.
Main Results:
- The proposed standardized parameters yield estimated CIED longevity values ranging from 5 to 17.2 years.
- Manufacturer-specific criteria often result in higher maximum longevity values compared to the standardized criteria for certain devices (e.g., CRT-D, CRT-P).
Conclusions:
- Standardized criteria offer a more consistent and comparable method for assessing CIED longevity.
- Manufacturer-defined longevity can be overestimated compared to standardized clinical assessments, impacting device evaluation.
- The developed criteria are essential for accurate health technology assessment and informed clinical decision-making regarding CIEDs.
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.
