Pacemakers and implantable cardioverter defibrillators (ICDs) deliver pacing and defibrillation (shocking) therapy through wires called leads. The leads can break down overtime and malfunction. Occasionally a pacemaker system will need to be upgraded to an ICD system. In both of these clinical scenarios (and in many others) new leads have to be added. Whenever a new lead is added a decision needs to be made about what to do with the leads that have malfunctioned or are no longer needed. The leads can be left in place (abandoned) or removed (extracted). There are benefits and risks to each approach. Whereas many cardiologists implant leads, very few have trained to extract them.
Spectrum Health is the only hospital system in Grand Rapids and the surrounding community with a lead extraction program and lead management clinic. The purpose of the lead management clinic is to offer patients a consultation with a lead management expert to ensure they understand the available options for treatment of a lead-related issue. The lead management clinic consultation helps patients to understand the benefits and risks of each course of action. For every patient, the risk of abandoning a lead needs to be weighed against the risk of lead extraction.
We have electrophysiology experts in lead management that are board certified. Our annual volume of lead extraction procedures is among the highest in the State of Michigan. We have state-of-the-art facilities and perform all of the extraction procedures in hybrid operating suites using the newest advancements in technology. We work as a team in collaboration with infectious disease, cardiology, electrophysiology, cardiothoracic surgery and anesthesia to care for patients that need lead extraction. We have a proven track record in safe and successful lead extraction.
Pacemakers and ICD leads are inserted through veins that travel to the heart and the ends of the leads are positioned inside the heart. Over time, scar tissue and adhesions can form causing the leads to become attached to the veins and heart muscle. Lead extraction is a procedure where the leads are removed using specialized tools that can free the leads from the scar tissue and adhesions. This can often be performed non-invasively through the pacemaker or ICD implant site using a laser or cutting tool. Lead extraction is a safe and effective procedure when it is performed by an experienced team.
There are risks associated with lead extraction that are avoided by abandoning leads. Leads are often abandoned because it is the easiest course of action and does not add any additional procedural risk.
As more leads are added there is greater risk of the veins that the leads travel through becoming occluded. If a vein becomes occluded it could cause arm swelling. If another lead were needed in the future having an occluded vein creates a scenario where lead extraction may be needed to make room for additional leads. Abandoned leads can interfere with the leads that are being used causing device malfunction. As more leads are placed through the tricuspid valve in the heart they may inhibit normal closure of the valve and cause leakage (regurgitation) which can cause congestive heart failure. If a lead is abandoned and extraction were needed in the future due to vein occlusion or infection, the procedure may be more difficult and risky because the abandoned leads will have been in place longer.1 Many new pacemaker and ICD systems are MRI compatible. Having an abandoned lead is an absolute MRI contraindication. This means that patients with abandoned leads cannot get MRI scans. In summary, the risks of lead abandonment include:
Lead extraction avoids the potential risk of abandoned leads including vein occlusion, device malfunction from lead interaction, tricuspid regurgitation, and infection. It also avoids the risk of a potentially more difficult and risky procedure if it were needed in the future for vein occlusion or infection. For each patient, the risk of lead abandonment vs. extraction will be different based on their age and clinical history.
All heart procedures have inherent risk. Life-threatening complications can occur during lead extraction, including tearing the veins that the leads travel through or perforating the heart muscle. In rare instances, open heart surgery may be needed to repair the injury. In a large study in which 3,258 patients underwent lead extraction, 25 (0.8%) patient’s required emergency surgery or other interventions due to life-threatening complications.2 The procedural mortality associated with lead extraction is 0.3%.3 There are approximately 70 lead extraction procedures performed at Spectrum per year and the number has been growing. Our safety outcomes are comparable to these published data.
We perform our cases in a hybrid operating room that has the x-ray equipment needed to remove the leads noninvasively. The operating room is equipped for emergency open heart surgery if necessary. In addition to a consultation with our electrophysiologist, each patient is also evaluated by a cardiothoracic surgeon prior to the case. The cardiothoracic surgeon and his or her team are immediately available if emergency open heart surgery is needed. In some centers this is not an option, and substantial delay can occur if there is an emergency. As an added precaution, in every case we also advance a guidewire through a vein in the groin to the area were the leads are extracted. This allows us to deploy a specially designed balloon that can stop bleeding if a vein tear occurred.