Pacemaker laser lead extraction or removal

photo_20090613_lead_removalOur practice specializes in removing leads (pacemaker and/or defibrillator wires attached to the heart) by minimally invasive procedure called as laser lead extraction.

The procedure involves use of laser sheaths that breaks up the scar tissue built around leads. The procedure is minimally invasive and requires considerable operator expertise. Our practice does the highest number of laser lead extractions per year in the state of Arizona.

What happens during the procedure?

The procedure is performed in an operating room under general anesthesia. Once the patient is prepared for surgery, the physician makes an incision close to the old device, and the generator is removed. The most difficult part of this procedure is not removal of the device, but removal of the leads. The level of difficulty is typically related to the amount of scar tissue that has formed since the device was implanted. If the wires are unable to be removed with gentle pulling, a special laser extraction device is used. This device consists of a sheath wrapped in laser fiberoptics that is advanced through the targeted vein and over the lead. The physician applies a controlled dose of laser energy to break up (ablate) any scar tissue and free the lead that is then pulled out.

Every circumstance is different, so your doctor will let you know if a new pacemaker or defibrillator system will be implanted at that time or after a course of antibiotics. Patients can expect to be in surgery for approximately four hours and are usually admitted to stay one night in the hospital for monitoring and observation if no further treatment is required.

laser glidelight

Why do leads need to be removed?

When a decision is made to implant a permanent pacemaker or implantable cardiac defibrillator (ICD), the laser 3expectation is that the device will remain in the patient’s body for the rest of his/her life. As with all medical devices, there are certain circumstances that require removal of the permanent system. Such circumstances include infection, inappropriate lead positioning, or lead failure which is often referred to as lead fracture or insulation breach. In addition, as cardiac pacing technology evolves, physicians may wish to upgrade a patient’s existing device with a newer more effective one.

The body’s natural response to a foreign object, such as a pacemaker is to form scar tissue surrounding the leads that course through blood vessels down into the heart. The longer the device remains inside the body, the more scar tissue will adhere to the leads, making removal difficult. Still, if the pacing device must be removed, leads cannot be abandoned, as they would interfere with new devices or cause damage to blood vessels.

There are a number of reasons that a physician might recommend extracting versus capping and leaving a lead in a lead in place:    

The lead is not functioning properly. Sometimes the lead no longer provides a reliable connection between the pacemaker or ICD and the heart. This can be due to damage to the lead, called lead fracture. Large amounts of scar tissue forming at the tip of the lead may also cause the lead to need more energy to function than the pacemaker or ICD is able to deliver.

A pacemaker infection or ICD infection has developed. The device and leads may need to be removed to cure the infection.

The lead is interfering with blood flow to the heart. Leads that are not being used may need to be removed if they are blocking the flow of blood to the heart.

There may be a manufacturer advisory on the lead. If a lead has a higher risk of failure than normal, it may be under a manufacturer advisory and need to be removed for safety.

MRI inaccessibility. Newer pacemaker systems are designed to be safe in an MRI environment; however, older, non-compatible pacemaker leads may prohibit access to MRI diagnostic testing.

Is laser lead extraction safe?

The procedure is successful in 97.7% of patients, and multiple clinical studies have demonstrated safety, effectiveness and efficiency of laser lead removal. The initial PLEXES trial (PLEXES Randomized Trial: Pacing Lead Extraction with the Excimer Laser Sheath) showed a significantly higher success rate in the removal of leads using the laser sheath over manual telescoping sheath tools alone: 94% vs. 64%, respectively.

The risk of internal bleeding, a tear in a vein or the heart, or death is very small; however, any medical procedure involves risks. Well-established professional recommendations and use instructions should be followed for every lead extraction procedure. Refer to Important Safety Information for Patients at the end of this media kit for complete information about risks.

What are the risks associated with this procedure?

Every medical procedure carries risk to your health, but in expert hands, laser lead extraction has about a 95 percent success rate, which is significantly higher than for the conventional procedure, known as percutaneous lead extraction.

Your doctor will discuss with you the risks and benefits of laser lead extraction. In general, this is a low risk procedure, but it does carry a one to two percent chance of life threatening complications. Common risks of this procedure include bleeding, bruising and infection where the incision is made. Less common risks include damage to the blood vessels, damage to the heart muscle, change in heart rhythm, heart attack, stroke, need for urgent cardiac surgery and death.

How does an excimer laser work?

Excimer laser is a “cool” laser similar to that used in LASIK for eye surgery. It produces pulsed bursts of UV light energy that are capable of gently dissolving fibrous tissue into tiny, microscopic particles that are easily absorbed by the bloodstream. This is also known as photoablation. This energy is transmitted along flexible glass fibers encased in catheters, which can be passed through arteries and veins. The UV light energy is then focused on the tissue that needs to be treated. The penetration depth is about 50 microns, or about the equivalent of the diameter of a human hair. The laser energy that is produced is absorbed by the binding tissue directly in front of the laser sheath tip, allowing a controlled removal of the lead.

What are the alternatives to laser lead removal?

Traction and non-laser sheaths are alternatives to laser lead removal. Traction is physically pulling on leads. The amount of traction required for lead extraction increases as the duration of the implant and the tensile strength of the fibrous overgrowth tissue increase. When fibrous tissue growth is substantial, traction alone is not sufficient. Other types of non-laser sheaths use different mechanisms to tear, cut or burn tissue away from the lead.

How long has laser lead removal been in use?

The pivotal randomized clinical trial demonstrating the safety and efficacy of the Spectranetics Laser Sheath (SLS) was completed in 1997. More than 15 years of clinical trials and publications continue to support the safety of the product.

Are there cases when the lead should not be removed?

When infection is present that does not involve the device or leads, when long-term antibiotics are required or when the patient has atypical lead placement, capping rather than removing the lead may be an appropriate solution based on physician evaluation.

There are important safety considerations to keep in mind, however: the risk of failed lead removal doubles every three years, and risk of infection increases 2% to 7% at each device change. Leaving non-functioning leads in place can also cause blood clots or blockages and prevent access for new leads. In some instances, there is “lead on lead” interaction that can cause electrical shocks or inappropriate pace/sense behavior in the device.

Recovery

After the procedure, patients may experience soreness, swelling and bruising at the site where the device and leads were removed. It takes approximately one week to physically recover from the surgery.

Click here to view Laser Lead Extraction Procedure Instructions

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