Pacemakers and implantable cardioverter defibrillators (ICD) are small devices that are placed in the chest or abdomen to help control abnormal heart rhythms. They both use pulses or shocks to help control these life-threatening arrhythmias and both consist of two parts: a generator and wires (leads or electrodes). The wires run from the generator into the heart’s chambers. They are attached to the heart muscle and will provide electrical signals from the generator as needed. During the life of the device it may become necessary to remove the wires. Typically, removal is required because of one of or more of the following reasons: (1) scar tissue has formed at the attachment point and around the lead, (2) damage has occurred to the inside or outside of the lead, (3) an infection is found at the side of the device or the lead, and/or (4) a blockage of the vein has occurred either by a clot or by scar tissue. The procedure to remove the wires is called a “lead extraction.”
A lead extraction is an extremely difficult procedure and carries with it a serious risk of injury or death. According to recent studies, approximately 10,000-15,000 lead wires are extracted annually worldwide. There are two approaches to lead extraction. The first approach is called the subclavian approach which involves extracting the wires through the upper chest over the subclavian vein. The second approach is referred to as the femoral approach which involves removing the wires through a small puncture in the groin over the femoral vein. In both approaches a special sheath (a tube) is placed inside the vein. This sheath is threaded over the lead and guided to the tip of the lead where it attaches to the heart. A laser light is then attached to the sheath to help break up scar tissue. After this is completed the lead can be removed.
Unfortunately, during the course of the procedure a physician may tear into the vein leading to the heart or may tear the heart itself. These tears will cause internal bleeding. This bleeding, given its location, may lead to death if not immediately addressed. Indeed, in cases where the superior vena cava is torn a delay of more than 10 minutes may prove to be fatal. Statistics show that the possibility of a major complication during a lead extraction, such a torn superior vena cava, can occur between 2 and 5.5 percent. Given the prevalence of a major complication and the stakes involved should one occur, it is distressing that even to this day the majority of lead extractions occur in Cath Labs. When done in this setting it will often mean that a cardiothoracic surgical team or a bypass machine is not in the immediate proximity. Once an emergency occurs the delays associated with the time taken to mobilize the surgeons or to get the patient to a bypass machine can result in death. As result, numerous hospitals have instituted policies requiring that lead extractions be performed in an OR with a cardiothoracic surgeon present. Although such a practice may not ensure a positive outcome it has been shown to greatly increase the chance of survival.
If you know of anyone who had a lead extraction done at a Cath Lab and who suffered a major complication then contact us. We may find that what occurred could have been prevented had proper procedures been in place.