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Published on: February 28, 2012
Feasibility and initial results of an Internet-based pacemaker and ICD pulse generator and lead registry
R Hauser1, D Hayes, V Parsonnet
1Minneapolis Heart Institute Foundation, 920 E. 28th St., Ste #300, Minneapolis, MN 55407, USA. rhauser747@aol.com
Insights
An online registry for pacemaker and implantable cardioverter-defibrillator (ICD) device failures provides timely data on performance issues. This system identified new problems and offered insights into device longevity and failure causes.
Area of Science:
- Cardiology
- Biomedical Engineering
- Medical Device Technology
Background:
- Lack of independent, timely data on pacemaker and implantable cardioverter-defibrillator (ICD) device performance.
- Need for a system to track pulse generator and lead failures in real-time.
Purpose of the Study:
- To establish and evaluate an Internet-based registry for tracking pacemaker and ICD device failures.
- To provide timely information on device performance, failure modes, and clinical consequences.
Main Methods:
- Development and implementation of an online registry (www.pacerandicregistry.com) for reporting device failures.
- Analysis of data collected during the first year of registry operation.
Main Results:
- Identification of three previously unreported device problems, communicated promptly to participants.
- 11% of ICD and 10% of pacemaker pulse generator failures occurred before the elective replacement indicator (ERI).
- Average battery longevity: 4.0 years for ICDs, 6.8 years for dual-chamber pacemakers. Lead failures: 54% pacemaker and 29% ICD due to disrupted insulation. ICD failures had more severe clinical consequences.
Conclusions:
- An Internet-based registry is a feasible method for collecting and disseminating timely data on pacemaker and ICD failures.
- The registry provides valuable insights into device failure signs, causes, and clinical impact.
- This system can enhance patient safety and inform medical practice regarding device performance.
Abstract:
The medical community has no independent source of timely information regarding the performance of pacemaker and ICD pulse generators and leads. Accordingly, the authors established an Internet-based registry of pacemaker and ICD pulse generator and lead failures (www.pacerandicregistry.com). During the first year, they found three previously unreported device problems that were promptly communicated to the participants. Of the failures reported, 11% of ICD and 10% of pacemaker pulse generator failures were heralded by signs other than the expected elective replacement indicator (ERI). Average ICD battery longevity was 4.0 +/- 0.7 years, and average dual chamber pacemaker battery longevity was 6.8 +/- 2.6 years. Disrupted insulation accounted for 54% of pacemaker and 29% of ICD lead failures. Compared to pacemaker pulse generator and lead failure, ICD device failures were more likely to cause severe clinical consequences. In conclusion, an Internet-based registry is feasible and capable of providing timely data regarding the signs, causes, and clinical consequences of pacemaker and ICD failures.
