Note on Scary Device Warnings

Are implantable heart devices safe?

You may have read or heard about the recent recall of pacemaker leads. If you have a pacemaker or ICD (implantable cardio-defibrillator), you may be worried that you’re in some kind of danger. Should you be? Keep in mind that “recall” doesn’t mean that you need to rush to your doctor and have the lead immediately removed. But you should probably visit your doctor and have a discussion about your particular situation.

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Here’s some background on these devices: The purpose of implantable defibrillators is to prevent sudden cardiac death, or SCD. It is estimated that 750 Americans a day die of SCD. One every 90 seconds. It claims more lives each year than AIDS, breast cancer, lung cancer or stroke. SCD is preventable by the use of ICDs. But sometimes people are alarmed by news reports about the safety of these devices.

So the world needs to know: Are implantable heart devices safe?

Yes, says Dr. Bruce Wilkoff, Director of Cardiac Pacing and Tachyarrhythmia Devices at Cleveland Clinic. Implanted cardiac devices help tens of thousands of people enjoy full, active lives. They are the most effective technology available for the prevention of sudden cardiac death.

Implantable defibrillators address the root cause of cardiac death – arrhythmia. An arrhythmia is a disturbance in the normal beating pattern of the heart. Cardiac devices use electronic pulses to help the heart stay on beat, or to jolt it back on track when it the beat gets out of control.

The pacemaker is the original implantable device and although a part of every ICD can also be used by itself. It monitors the heart beat and prevents the heart rate from going too slowly. When the heart tries to beat too slowly, the pacemaker delivers a mild electronic pulse to increase the rate to normal.

An ICD, is quite different. This device quickly detects abnormally rapid heart rates which can lead to sudden cardiac death. The ICD delivers a high-energy shock that restores the heart to its normal rhythm, preventing sudden cardiac death.

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The third type of device is a special kind of pacemaker that helps the heart to beat more efficiently. This type of pacemaker is called a biventricular pacemaker. It uses a third lead to coordinate the two lower chambers of the heart.

Finally, there’s the biventricular ICD. This combines the functions of a biventricular pacemaker and an ICD. It is used in people with heart failure who are at higher risk of sudden cardiac death.

To understand the safety of these devices, it’s good to know how they’re put together. Each consists of two parts – a small metal generator, and one or more wires, called “leads.” The generator contains a battery, an antenna, and a small computer. The leads are implanted in the heart. They deliver information to the computer. The antenna delivers information to your doctor. When the computer senses a rhythm disorder, it tells the battery to send an electrical pulse to correct it.

The U.S. Food and Drug Administration issues safety advisories on pacemakers, ICDs and their leads as it becomes clear that they may be at some risk of not working as they were intended. A safety advisory or recall is only a warning. It does not mean that every device will malfunction and in fact usually only a very small number do fail to work as intended. And when they do show a problem most device malfunctions don’t end up being harmful to the patient.

As Dr. Wilkoff points out, these devices are manufactured to very high reliability standards.

Some devices may have a problem in their computer software. Fortunately, this can be solved by downloading new software, a non-invasive procedure that can be done in a doctor’s office.

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A malfunction in the lead wire or its insulation may prevent an ICD from delivering its life-saving jolt. An ICD may have other, non-life-threatening malfunctions. These are very rare, occurring in only about 2 percent of all cases. Sometimes a device needs to be surgically removed or replaced.

Dr. Wilkoff notes that the vast majority of patients with malfunctioning devices, the risks of surgery outweigh the risks of a device malfunction.

If you have a device that has been listed in a safety advisory or recall notice, ask your doctors these questions: What is the risk of your device failing? What is the actual danger to yourself if the device fails. What are the risks of having the device replaced? What are the alternatives to having the device changed?

Dr. Wilkoff appreciates the value of safety advisories. They alert physicians to the need for certain precautions and more follow-ups. But at Cleveland Clinic, he and his colleagues continue to have confidence in the overall safety and effectiveness of implantable cardiac devices.

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