Update on Laser Lead Extraction

In recent years, lead extraction has become an increasingly common procedure which has moved from the realm of cardiothoracic surgery to interventional cardiac electrophysiology. This article reviews indications for lead extraction and briefly discusses the common approaches currently employed to remove leads. Indications Several converging trends have driven the increase in lead extraction procedures. Twenty years ago, most patients needed to survive a cardiac arrest twice before implantable cardioverter-defibrillator (ICD) implantation would be considered. Today, most implantations are prophylactic, with no demonstrable arrhythmia needed to meet current implant guidelines.1 Not surprisingly, as more devices have been implanted, and the patients receiving these devices are older and have complex medical comorbidities, the number of device infections has risen dramatically.2 Coincident with expanding indications for implantation, devices themselves have grown more complex in their design. While this new design complexity has allowed for a dramatic expansion in the functional capabilities of leads and generators, some components of these reengineered devices have suffered from design failures. Instances of lead fracture (Medtronic’s Sprint Fidelis) and perforation (Telectronic’s Accufix atrial J lead, St. Jude’s Riata) have been well documented and pose a management challenge for physicians. In many cases of existent or potential lead failure, clinicians have elected to extract problematic leads. Even in leads without a clearly evident design flaw, authors have noted that leads wear out at a predictable rate, which has been estimated to be as high as 20% over 10 years.3 Careful examination of longevity curves for leads may result in a significant number of lead extractions in appropriately selected patients. In general, the indications for lead extraction are summarized below.4,5 The guidelines will be updated during the upcoming Heart Rhythm Society meeting later this month. Infection of an implanted cardiac device. Whether the infection is in the pocket or a vegetation on the lead, it is unlikely to clear with antibiotics alone, and most centers of excellence recommend complete device explantation. Mechanical failure or impending failure of an existing system. If a patient requires surgical revision based on the elective replacement indicator and has a lead with a high probability of lead failure based on the natural history of that lead, extraction and replacement of the lead should be considered on a case-by-case basis. Venous access for device revision/upgrade. If no access to the central circulation on the desired side is possible, extraction of even a normally functioning lead can be considered to permit upgrade to a more complex system. Patient request for discomfort or cosmetic reasons. This is a very rare indication. Lead Extraction Lead extraction is a technically challenging procedure. After initial lead implantation, areas of thrombus form on the newly inserted foreign body. This thrombus organizes and fibroses, with areas of fibrosis causing the lead to be tightly attached to the vascular endothelium in characteristic locations. In general, the longer the lead has been in place, the greater the extent of fibrosis.6 Lead extraction, then, involves not only retraction of the lead from its attachment to the myocardium, but is also dependent on freeing the lead from the fibrous sheath that anchors it to the vasculature. In general, methods of traction and counter-traction are utilized simultaneously to remove a lead from the body.7 In this approach, the lead of interest is retracted to serve as a guide rail over which a sheath is advanced to free the lead from fibrous attachments to the vasculature. The sheath is advanced over the retracted lead until the myocardial interface, at which time the sheath is held firmly against the myocardium to localize maximal traction to the small area of myocardium to which the lead is attached. The dramatic increase in successful percutaneous lead extractions has been dependent on an explosion in the number of efficacious tools available to the physician to aid in the application of the traction/counter-traction approach. Direct traction on leads carries with it the risk of insulation avulsion as the tension applied to the lead tends to be transmitted unevenly. The advent of locking stylets, which pass through the inner lumen of the lead to the lead tip and then expand (either focally at the lead tip or more diffusely, along the length of the lead), allows for traction to be more evenly transmitted and greatly reduces the risk of lead avulsion. Sheath design has also improved substantially. Telescoping sheaths are now available in Teflon (Dupont, Wilmington, Delaware), polypropylene and stainless steel forms. Teflon is more compliant than steel, and alternation between different sheaths can be helpful when navigating different portions of the vasculature. For instance, when a calcified area is encountered, a steel sheath may be of use. Alternatively, when an acute bend is seen, a more compliant Teflon sheath may minimize the risk of vascular injury. In addition to telescoping sheaths, manually powered sheaths are available that make use of rotational energy as well as traction and counter-traction. The Cook Vascular Evolution lead extraction sheath (Cook, Inc., Bloomington, Indiana) is a plastic sheath with a rotating metal tip. The handle of the sheath is pumped, and this pumping action results in rotation of the metal tip, which in turn disrupts fibrous attachments. This sheath has been reported by some authors to be particularly useful in dealing with areas of significant calcific adhesion. Femoral approaches to lead removal, although efficacious in experienced hands, are utilized less frequently to remove leads, in part because of the difficultly encountered when dealing with significant fibrotic adhesion along the lead body. While the direct surgical approach remains an option, laser-assisted lead extraction may be emerging as the procedure of choice for removal of long-standing leads.7 Laser Lead Extraction The Excimer Laser System (Spectranetics Corp., Colorado Springs, Colorado) also utilizes a sheath which is passed over the lead. The tip of this sheath, however, emits pulses of laser light in a radial pattern at a wavelength of 308 nm. These pulses penetrate only 100 micrometers beyond the sheath tip, breaking up the fibrotic attachments between the lead and the endovascular surfaces at the interface with the sheath without causing far-field collateral damage. Initial preparation of the lead for laser extraction is similar to preparation of leads for extraction by nonpowered sheaths. The lead to be explanted is first transected, and the inner lumen identified. A locking stylet is then passed down the lead to secure it from the tip. A suture is then used to secure the outer insulation of the lead to the locking stylet. The beveled laser sheath is then advanced over the lead and locking stylet under fluoroscopic guidance while gentle traction is applied to the locking stylet. At areas where resistance is encountered to advancement of the sheath because of presumed fibrotic tissue, brief applications of laser energy are applied with the sheath coaxial to the lead and vessel until the sheath advances freely with minimal resistance. At all times, but in particular at the curve as the lead approaches the superior vena cava, care must be taken to ensure proper orientation of the bevel. The lead tip is generally removed without application of laser energy with simple traction and counter pressure utilizing the laser sheath. After the lead is removed a guidewire can be placed through the sheath into the central circulation to retain access for subsequent lead reimplantation. Data for laser assisted lead extraction appear promising.8 In the PLEXES trial, patients randomized to the use of a laser sheath as opposed to standard sheaths were more likely to have a successful complete lead removal (94% vs. 64%, p = 0.001) and to have their leads removed in a shorter period of time (10.5 ± 11.5 minutes vs. 12.9 ± 19 minutes, p = 0.04). An excess mortality in the laser sheath arm of the trial was not statistically significant. Even more impressive data from a highly experienced lead extraction center comes from the group at Brigham and Woman’s Hospital. From 2000 to 2007, 975 leads were extracted from 498 patients. Application of laser energy was required in over three-quarters of these extractions. This group reported a 97.5% complete removal rate, a 1.0% minor complication rate, a 0.4% major complication rate, and no mortalities. Safety Lead extraction is a technically challenging procedure with an associated learning curve. Not surprisingly, a retrospective analysis of data from the previous decade suggested a clear difference in morbidity depending on operator experience. Even in experienced hands, potential complications from lead extraction include perforation of the heart or central circulation resulting in tamponade or hemothorax, an embolic event, deep venous thrombosis, and pocket hematoma. While complications are infrequent in high-volume centers, they can be rapidly catastrophic if not handled quickly and expertly. In institutions where the lead extractor is not a cardiothoracic surgeon, common practice is to have a cardiothoracic surgeon and bypass equipment on standby in the event of a complication. Often, the extraction is performed in an operative suite. In a retrospective review of the Mayo Clinic experience,10 leads that were abandoned did not result in any demonstrable increase in thromboembolic complications, sensing malfunction, inappropriate shocks or defibrillation threshold. Obviously, this cohort of patients was preselected by the lack of referral for lead extraction; however, it does give pause regarding the strategy of removing all nonfunctioning leads. Conclusions There are at present no firm guidelines for lead extraction, and the relative risks and benefits should be considered on a case-by-case basis. In general, device infection mandates lead removal. More complex decision-making sometimes accompanies the option of extracting a noninfected lead. Considerations of lead age, lead failure rate, pacemaker dependency, lead size and design and number of leads cohabitating within a single vessel all have an impact on the decision as to whether to remove a lead. The more comfortable an operator becomes with the extraction procedure the more readily it is employed; which is appropriate as the operators who are more comfortable with the procedure are undoubtedly further along the learning curve and have lower complication rates. Additionally, the operative risks must be individualized. In an elderly patient with multiple comorbidities, it is sometimes more prudent to just place an additional lead alongside the nonfunctioning one as long as there is access to do so, whereas in a younger patient who might expect to need several leads over a lifetime, alternative considerations may come into play. Familiarity with the full array of complementary techniques and technologies will increase the likelihood of successful extraction.

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2. Cabell CH, Heidenreich PA, Chu VH, et al. Increasing rates of cardiac device infections among Medicare beneficiaries: 1990–1999. Am Heart J 2004;147:582–586.

3. Kleemann T, Becker T, Doenges K, et al. Annual rate of transvenous defibrillation lead defects in implantable cardioverter-defibrillators over a period of > 10 years. Circulation 2007;115:2474–2480.

4. Sohail MR, Uslan DZ, Khan AH, et al. Management and outcome of permanent pacemaker and implantatable cardioverter-defibrillator infections. J Am Coll Cardiol 2007;49:1851–1859.

5. Love CJ, Wilkoff BL, Byrd CL, et al. Recommendations for extraction of chronically implanted transvenous pacing and defibrillator leads: Indications, facilities, training. North American Society of Pacing and Electrophysiology Lead Extraction Conference Faculty. Pacing Clin Electrophysiol 2000;23:544–551.

6. Smith HJ, Fearnot NE, Byrd C. Where does scar tissue form to inhibit extraction of chronic pacemaker leads? J Am Coll Cardiol 1992;19:148A.

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8. Wilkoff BL, Byrd CL, Love CJ, et al. Pacemaker lead extraction with the laser sheath: Results of the Pacing Lead extraction with the Excimer Sheath (PLEXES) trial. J Am Coll Cardiol 1999;33:1671–1676.

9. Jones SO, Eckart RE, Albert CM, et al. Large, single-center, single-operator experience with transvenous lead extraction: Outcomes and changing indications. Heart Rhythm 2008;5:520–525.

10. Glickson M, Suleiman M, Luria DM, et al. Do abandoned leads pose risk to implantable cardioverter-defibrillator patients? Heart Rhythm 2009;1:65–168.