Pacemaker and ICD Lead Extraction: New Indications and Sheath Technologies

Steven P. Kutalek, MD, FACC, Director of Clinical Cardiac Electrophysiology at Hahnemann University Hospital and Associate Professor of Medicine at Drexel University College Medicine, and Christine S. Saari, MSN, CRNP Drexel University College of Medicine Philadelphia, PA
Steven P. Kutalek, MD, FACC, Director of Clinical Cardiac Electrophysiology at Hahnemann University Hospital and Associate Professor of Medicine at Drexel University College Medicine, and Christine S. Saari, MSN, CRNP Drexel University College of Medicine Philadelphia, PA
Extraction of permanent pacemaker and transvenous defibrillator leads has become an accepted method of treatment for patients with a variety of explant indications. These include lead malfunction, local infection or sepsis, vegetations, vascular overload, and the presence of unnecessary leads in patients who would otherwise be required to live with those leads for many years. Concomitant with the increasing indications for device implantation, prolonged survival of patients with implanted devices, more frequent device replacements, and the younger ages of implantation for prophylactic devices, the need for lead extractions continues to increase.1-3 Technologic advancements in the tools available for lead extraction have enabled safe procedures, best performed with adequate training and a skilled hospital support team. Identification of the appropriate patient and long-term follow-up, especially for infections, are mainstays of effective and successful patient management. The newest indications and patient management guidelines are described in the Heart Rhythm Society consensus document published in 2009.4 There are some important changes in lead extraction indications. First, pocket erosion is clearly recognized as a reason to remove both the generator and leads. All other infections of the generator or leads, including everything from local draining fistulae to recurrent sepsis or endocarditis with vegetations,5 are reasons to explant and extract. Most importantly, nonfunctional leads and vascular overload with multiple leads now take higher prominence on the list of reasons to extract. Especially important are leads that are no longer needed or have failed in young patients. Whereas previously these leads would have been left in place and capped, there is now general consensus in the extraction community that they should be removed. This may prevent long-term complications that can develop from leaving the leads in place, such as vascular occlusion or SVC syndrome, which are more apt to occur if more than four leads enter either the axillary or subclavian vein or if more than five leads pass through the superior vena cava.4 Crossing points of all these leads inside the venous system are areas particularly prone to heavy fibrosis. Leaving the leads in place when they could otherwise be extracted makes removal several years later (if required for infection, for example) more problematic due to increased degrees of fibrosis over time. Recent publications indicate the safety and efficacy of laser for lead extraction through studies performed at multiple institutions; success rates are high and procedural risks have been reduced with training and advancements in laser design.6,7 The criteria for laboratory preparation and training are included in the Heart Rhythm Society recommendations published last year.4 Full access to CT surgery, echo, and invasive monitoring are required. Even with adequate preparation, complications can occur, though the rate of complications appears to be reduced with newer technologies, greater experience, and appropriate patient selection to overall morbidity rates of 1-1.5% and overall mortality rates of 0.2-0.5%. Even these numbers speak toward performing extractions in an institution prepared to manage complications.7 Transvenous lead extraction traditionally has involved the use of mechanical polypropylene or Teflon sheaths to remove pacemaker or ICD leads by breaking up fibrotic and calcified scar tissue along the lead course. Even with the advent of powered sheaths (e.g., laser or electrosurgical cautery systems), an outer mechanical sheath is still commonly used. The outer sheath is also still used with traditional mechanical telescoping sheaths, as well as with rotational cutting sheaths. The outer sheath has the advantage of supporting the inner, often powered, sheath to prevent kinking, and it also provides a means to break through calcified areas through which a laser or other powered sheath alone may not pass. Though the benefits of an outer sheath are clear, early generations of these sheaths pose challenges to the operator. First, the outer sheaths themselves can kink, requiring their removal and replacement with a new sheath system. Second, the sheaths may not have the stiffness needed to break through heavy calcium, in that the tips may bend and collapse on themselves when a tough lesion is approached. Third, the sheaths may not torque properly when they encounter areas of heavy fibrosis or calcium, not delivering rotation at the tip comparable to the force applied by the operator; clearly, they do not have one-to-one torque characteristics in this regard. Finally, they are difficult to see under fluoroscopy. This might require magnified views or increased x-ray dosage to the patient and operator. The design of the new VisiSheath™ (Spectranetics, Colorado Springs, CO) surpasses many of these concerns. It was developed with the major issues of firmness, visibility, and ability to torque effectively in mind. The sheath is stiffer than its counterparts, but not so stiff that it would not allow the inner SLS® II laser sheath (Spectranetics, Colorado Springs, CO) to flex around the vasculature to reach the right ventricular apex. Its stiffness, though, allows the operator to have better control over the tip, with torque characteristics that much more closely resemble one-to-one control than its predecessors. It is difficult to kink, even without a laser sheath inside. This stiffness enables the sheath to readily break through heavy scar tissue and calcium along the course of the lead being extracted. As important as the handling characteristics, it is easier to see on fluoroscopy. The sheath itself, constructed with new materials, is more visible throughout its course during the procedure. Additionally, a prominent radio-opaque ring near the distal tip marks the end of the sheath, with the beveled tip protruding just beyond the ring. Because of its enhanced visibility, the operator can more readily keep the pointed bevel of the sheath toward the inside of the curvature of the superior vena cava and major veins, following the laser bevel, to avoid damage to the vessel wall. This enhances safety, reduces the need for high-intensity radiation exposure or magnification, and ultimately leads to reduced procedure time because the operator can actually see the sheath during the procedure using only low-dose fluoroscopic imaging. Case Presentation The patient is a 78-year-old male who had original implantation of a dual chamber ICD, with a bipolar active fixation atrial lead and a dual coil active fixation high energy ventricular lead, in March 2006 for primary prevention of ischemic cardiomyopathy. In September 2009, he experienced multiple ICD shocks due to conductor fracture in the RV lead. At that time, in a center that does not perform lead extraction, the decision was made to cap the high energy lead and place a second dual coil high energy RV lead as well as upgrade the device to a biventricular ICD system due to progression of his cardiomyopathy and the onset of congestive heart failure symptoms. Unfortunately, the ICD pocket became infected. On presentation to the lead extraction service of Drexel University College of Medicine, his device showed signs of incipient erosion, with adherence of the skin to the lateral border of the device, associated with erythema, thinning of the skin, and pocket effusion. At operation to remove the device, the pocket was found to be infected internally, requiring debridement, although primary closure was possible with placement of a drain. (Figure 1) The coronary sinus lead was removed with traction alone. Likewise, the most recently implanted RV lead was also removed with direct traction. The two leads from 2006 were fibrosed into position along their course, as demonstrated by gentle traction on the leads. The decision was made to use laser extraction sheaths for removal of the leads. According to our laboratory protocol, the lead most likely to be easiest to remove, in this case the atrial lead, was approached first. A 12 French laser sheath was selected after unscrewing the lead from the endocardium and advancing a locking stylet to the tip of the lead. A small (size S – compatible with the 12 Fr laser sheath) VisiSheath was used as an outer sheath. The 12 Fr sheath size was selected because it would have the closest fit to the atrial lead’s outer diameter. Figures 2A and 2B show the sheath advancing in conjunction with the laser through the left subclavian and brachiocephalic veins, where fibrosis was first encountered. The lead was removed in its entirety without incident. The dual coil active fixation high energy ventricular lead was approached next. The lead could not be unscrewed from the endocardium; this does increase the difficulty of removal. A locking stylet was advanced to the tip of the lead and locked into place. Heavy #0 silk ties were place around the high energy wires and also around the body of the lead for additional traction. A 14 Fr laser sheath was selected in conjunction with a Teflon outer sheath. Figures 3A and 3B show the standard Teflon sheath being used in conjunction with the laser sheath to remove the ICD lead from the subclavian and brachiocephalic veins, where fibrosis was also first encountered with this lead. The lead was removed in its entirety without incident. At that point, the pocket was debrided of all infectious material and a Jackson-Pratt drain was placed in the inferior-lateral corner and exteriorized. The patient was hemodynamically stable at the end of the procedure and was transferred to telemetry for further care. In this situation, it is not uncommon to require inotropic support since the coronary sinus lead has been removed, which, if effective, would have been enhancing LV contractile function. Discussion This case demonstrates many of the principles discussed above. The indication for extraction is clear — a pocket infection that involves the leads as well as the generator thereby requires removal of the entire system. The likely cause of infection was generator replacement and upgrade of the system, a reoperation, which carries a higher risk of infection than initial implantation of a device. This may be due to chronic indwelling hardware, an avascular chronic capsule, prolonged duration of the procedure, or any combination of these factors. The infection was likely indolent and present for months, leading to device pre-erosion. This case also raises the consideration as to whether the dual coil active fixation high energy ventricular lead should have been removed at the time of device replacement. At a skilled lead extraction center such as ours, we would have recommended removal of the chronic ICD lead rather than placement of a second high energy lead. The extraction procedure would have been performed at our center at the time of repair of the fractured ICD lead to avoid vascular overload and lead-to-lead interaction. The fluoroscopic images in the case presented demonstrate the differences in visualization between a standard outer Teflon sheath placed around a laser compared with the VisiSheath. The body and its tip are easier to see under the same fluoroscopic image intensity than the standard Teflon sheath. Additionally, the firmness of the VisiSheath enabled the removal of the dual coil active fixation high energy ventricular lead with reduced mechanical force. The VisiSheath can be used for countertraction at the cardiac surface, much as any other sheath would be used to facilitate lead removal. It is flexible enough to track over a laser sheath to the distal end of the lead. Its added stiffness also improves venous entry through heavily calcified or fibrotic tissues in the subclavian area. It can also be used as an outer sheath in conjunction with standard polypropylene extraction sheaths. Summary Indications for lead extraction have expanded, concomitant with increased indications for device implantation, especially for high energy ICD systems. Technologic advances in laser and sheath design have enabled the removal of a very high percentage of leads, over 97% in most current series, with relatively low morbidity and mortality rates — certainly lower than if thoracotomy were required for removal of all these systems. Further, the process of transvenous lead extraction has been enhanced with improvements in extraction tools, allowing the operator a wider variety of equipment from which to choose, tailoring the approach to the individual patient. Overall, we believe the VisiSheath provides greater firmness and torque characteristics, reduced ability to kink, and enhanced visibility under low dose fluoroscopy, factors which improve patient safety and reduce procedural time. Disclosure: Dr. Kutalek is a consultant for Spectranetics Corp. Christine S. Saari, MSN, CRNP has no disclosures to report. Editor’s Note: This article underwent peer review by one or more members of EP Lab Digest’s editorial board.