CIED Management

Most patients with CIEDs have an uncomplicated course and management largely involves routine checks and, when needed, a procedure to change the generator (battery). However, as with any medical device, issues can occasionally arise. These issues are uncommon but being aware of potential problems can help you alert your doctor.

Most CIED issues can be categorized as programming, device or lead malfunction, and infection. Since your doctor will be getting information from the CIED, he or she will typically be the first to recognize problems with programming and device or lead malfunction.

By being alert to any unusual changes at the device site or systemic signs of infection, you may be the first to recognize an infection. It is important to remember that CIED-related issues are uncommon, but by being aware of potential problems and alerting your physician early if you think there is a problem, you can help improve your care.

Reprogramming is a routine part of CIED management. This can be done wirelessly through the skin during an office visit. For example, resting heart rate and heart rate response to exertion can be reprogrammed to better tailor the device to your needs and energy output can be adjusted to ensure reliable pacing and conserve battery. Regular follow-up for the device through office visits and remote monitoring will help your physician ensure that your CIED is programmed optimally.

While antibiotics are an important part of treatment for CIED infection, on the surface of the generator and leads, bacteria can effectively wall themselves off from the antibiotic. For this reason, when a CIED becomes infected, the device and all of the leads will typically need to be removed (extracted) to help clear the infection. Managing any infection related to your device is critical to your health. It is important to talk to your doctor about the presence of a systemic infection, pocket infection or endocarditis. While there is medical evidence that support removing the system including extraction of the leads, many factors can influence this decision. It is important to talk to your doctor about your options.

While infections are uncommon, an infection is a serious complication and one you should understand and be aware of. The physical presentation and effects of an infection will vary by individual as well as the source, and type, of the infection.

A device infection may start in the pocket or originate elsewhere in the body – such as from a urinary tract infection or a cut. The infection can enter the bloodstream and attach to the device. If you see or feel signs of infection or notice any changes in the tissue or skin overlying the device, contact your doctor or device manager.

Symptoms of Infection may include:

• Fever
• Sweating
• Chills
• Fatigue
• Nausea

Visual signs of Infection that can be observed at the skin around your pacemaker may include:

• Redness of the skin
• Pain or tenderness
• Swelling
• Warmth or "hot" feeling
• Blood, pus, or other drainage
• Skin ulcers
• Erosion of the device through the skin

For a brochure of these signs of device infection, download Your Guide to Cardiac Device Health.

Watch one man's story about the importance of alerting your doctor of your symptoms:

While battery depletion is expected and, after years, will typically require replacement of the CIED generator, most other types of device and lead malfunction are rare. In some cases, device reprogramming will allow continued use of a lead even when it is not functioning optimally. However, many forms of device and lead malfunction require surgery to replace the malfunctioning CIED generator or lead. When a lead is replaced by a new one, the old lead can either be left in place (abandoned) or removed (extracted). You and your doctor will decide which treatment is best for you through the shared decision-making process.

Watch a story about one man's journey:

Other issues that may require management decisions regarding the CIED and leads. These issues might require a decision to either abandon or extract CIED leads:

• Manufacturer's Advisory
  • An advisory from the lead manufacturer outlining that there are potential safety issues or product defects with a lead
• Chronic Pain
  • Severe chronic pain as a result of an implanted device
• Device Upgrade/Generator Change
  • If a device is being upgraded (for example from a Pacemaker to an ICD) or is undergoing a battery change, one or more of your existing leads may no longer be needed
• Occlusion
  • Rarely, the presence of a lead can result in clotting, narrowing or occlusion of the vein. This in turn, can cause swelling or discomfort and can interfere with insertion of a new or additional lead.
• MRI Contraindications
  • There is medical evidence supporting the safety of an MRI for patients with abandoned and non-conditional devices and leads. It is important to speak with your doctor about your device and leads before you have an MRI.

If the time comes when you and your doctor decide the best decision for your health is the removal of certain parts or your entire device, your doctor, or a colleague, will perform a lead extraction procedure. During the procedure, a doctor will advance a flexible tube (sheath) over the lead, gently freeing the lead by removing scar tissue. Some of these sheaths can deliver laser energy to the scar or are tipped with very small cutting blades designed to cut away at the scar. Your doctor will continue this process until all targeted leads for removal are safely extracted.

Resources

• Cleveland Clinic: Lead Extraction
• Consult QD: Leading from Experience in Transvenous Lead Extraction

Treatment decisions should be based on consultation with your doctor. Lead removal may not be appropriate for some patients depending on their health factors. 

Lead extraction is generally a very safe procedure. However, as with any invasive procedure, there are risks. Although results and risks vary from patient to patient, the clinical research shows clinical success rates around 98%. The clinical research shows that the risk of internal bleeding, tears in a vein or heart, or death is less than 0.5%. It is important to talk to your doctor about the risks.

Resources

• Cleveland Clinic: Lead Extraction Risks/Benefits

It is important to know your CIED management alternatives. Unless an infection is present or the presence of a device is causing (or will cause) significant health issues, you and your doctor may decide to leave a lead in your body. This is referred to as abandoning a lead. Abandoning a lead in the body may also pose some risk which must be considered in the lead management decision.

When no infection is present, the risks of abandoning a lead could include:

• Increased risk of future device infection
• Future extractions may be more difficult or have worse outcomes due to potential increased scarring and adherence around abandoned leads
• Having an abandoned lead may complicate the ability to get an MRI
  • 75% of patients with a CIED will need an MRI in their lifetime but depending on the type of abandoned leads, they can be a contraindication for an MRI.
• Increased risk of scarring or damage to the structures of your heart.

Each patient and each journey is different. It's important that you understand the entirety of the device implanted in your body and everything that comes along with it, including ongoing device management. Be a proactive advocate for your health and know what signs and symptoms to look out for by downloading this quick tips infographic. HRS recommends that you monitor your device and play an active part in the shared decision-making process with your doctor regarding your CIED.