Proposed Guidelines regarding Device Performance: Pacemakers and ICDs

Reviewed by Dr. Bruce Wilkoff
Director, Cardiac Pacing and Tachyarrhythmia Devices,
Cleveland Clinic Foundation

Three published studies in the 2006  Journal of American Medical Association (JAMA)* ^1-3 addressed the complex issue of pacemaker and implantable defibrillator (ICD) malfunction.  These studies are still relevant today.

Poor device performance can be related to the device itself or the leads (wires) that are implanted into the heart. In either case, if a patient is dependant on a device to treat a life-threatening arrhythmia, and the device does not work properly, the patient can be at risk.

Two of the JAMA articles analyzed the rate and pattern of device malfunction ^1-2, and the third article discussed the risk of re-operation in response to the recent advisories recalls ³.

The articles comment on several points related to pacemaker and ICD function:

• Despite the technological advances of implanted devices, device malfunction has decreased in the past 20 years. However, device malfunction still remains a potential complication. The risk is about 7 in 1,000 for pacemakers and almost double that for ICD devices.
• Poor device function can occur more than three years after the device implant.
• A device malfunction is not usually harmful to the patient.
• The causes of device dysfunction can be related to lead or device design, physician technique, patient activity, and patient anatomy.
• The risks associated with ICD device removal can be as great or greater than the risks of device malfunction. Complications occurred at a rate of 8.1% and ranged from minor to severe (5.8%) ³. These risks need to be considered when determining the appropriate treatment for patients who receive a device advisory.

Study Conclusions

The studies conclude that ICDs and pacemakers are important and life-saving devices. However, more information and careful monitoring are needed to help track device performance and determine causes of malfunction.

Heart Rhythm Society released proposed guidelines

Concurrently with the publication of these articles, the Heart Rhythm Society released a draft of recommendations for the monitoring, analysis and performance reporting of pacemakers and implantable cardioverter defibrillators (IC Ds) ⁴.

The following is from the Heart Rhythm Society press release dated April 26, 2006:

"The guidelines outline the recommendations to physicians, the Food and Drug Administration (FDA), and Congress about performance issues and advisories for implanted cardiac devices. The recommendations also provide heart patients with clearer, timelier and more consistent information about the recall and advisory process.

The draft guidelines call for:

1. Greater transparency in the post-market surveillance, analysis, and reporting of information
2. The establishment of new systems to identify malfunctioning devices more quickly and
3. Standard notification and communication to physicians and patients from the manufacturer when a device malfunction is identified.

Manufacturers, the FDA, and physicians are encouraged to work together to prevent adverse events due to device malfunctions.

Select highlights from the recommendations include the following:

Physicians:

• Should inform patients not only about the benefits and risks of devices, but also about the overall expected performance of devices, including potential malfunction rates.
• Should return all malfunctioning devices after explant to the manufacturer for analysis whether the replacement is routine or because of a malfunction. This will lead to more timely identification of potential malfunctions and a better understanding of the true 'denominator' for a particular device.
• Should consider the risks of explantation and re-implantation of a new device when considering with their patients how to respond to an advisory notice that a device malfunction has been identified.

Manufacturers:

• Should use expanding wireless and remote monitoring technologies to identify abnormal devices earlier and automatically.
• Should establish independent, standing committees of outside experts to analyze device performance reports and to recommend appropriate action.
• Should communicate with patients directly using standard patient communication forms to notify patients regarding potential malfunctions.

FDA:

• Should use simple language to communicate important information about device malfunctions and eliminate the term "recall" in public communications.
• Should enhance the existing databases to more readily identify devices that may pose a danger to patients.
• Should establish a post-marketing surveillance advisory panel of independent expert advisors to assist FDA with this function

Congress:

• Should recognize the FDA needs additional resources and funding to perform post-market surveillance, analysis and reporting."

Learn more about the Heart Rhythm Society, ICD recalls, and guidelines.*

References:

1. Maisel WH. Pacemaker and ICD Generator reliability: meta-analysis of device registries. JAMA. 2006;295:1929-1934.*
2. Maisel WH, Moynahan M, Zuckerman BD, et al. Pacemaker and ICD generator malfunctions: analysis of Food and drug Administration annual reports. JAMA. 2006;295:1901-1906.*
3. Gould PA, Krahn AD, the Canadian Heart Rhythm Society Working Group on Device Advisories. Complications associated with implantable cardioverter-defibrillator replacement in response to device advisories. JAMA. 2006;295:1907-1911.*
4. Heart Rhythm Society: Heart Rhythm Society Issues Recommendations on Performance Policies for Pacemakers and ICDs, September, 2006.
5. Wilkoff BL. Pacemaker and ICD Malfunction – An Incomplete Picture. JAMA. 2006;295: 1944-1946.*

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Copyright 2006-2009 Cleveland Clinic. All rights reserved. reviewed 9/09