Lead management frequently asked questions

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:

• Vein occlusion
• Device malfunction due to interference with other leads
• Tricuspid regurgitation
• Potentially more difficult and dangerous extraction if needed in the future
• Exclusion from MRI scans

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.