In this interview, Dr. Bruce Wilkoff discusses the Lead Extraction in Contemporary Settings (LExICon) study data, the updated lead extraction guidelines, as well as his use of laser lead removal. Dr. Wilkoff is the principal investigator of the LExICon study and the Director of Cardiac Pacing and Tachyarrhythmia Devices at the Cleveland Clinic. Tell us about the LExICon study. What was the purpose of the study, and what were the key results? The purpose of LExICon was to examine the outcomes of laser-assisted transvenous lead extraction in a multicenter evaluation in experienced lead extraction centers. Previous results of extraction have either been from a single site experience or multicenter evaluations that occurred early in the experience with lead extraction, and included the learning curve with lead extraction with the learning curve with laser use with the development curve as laser tools were improving. The key results are that the risk of transvenous lead extraction is relatively low in centers with experienced operators; however, patients that receive transvenous lead extraction often have advanced illness (e.g., diabetes, renal insufficiency and infections), which carry significant morbidity and mortality. Even so, the efficacy of transvenous lead extraction is significantly improved when the lead extraction volume is large, even in experienced hands. What is significant about the LExICon study? How do the results affect electrophysiologists’ lead management options? LExICon helps us to understand that the patient’s risk depends more on the condition of the patient and indication for the extraction than other factors. In particular, patients with pocket infection without evidence of systemic infection are at almost 6 times the risk of dying during their hospitalization than people without infection, and patients with systemic infections have 14 times increased risk of death. The risk is not from the extraction, but from the infection. The risk is even higher when patients have kidney dysfunction or diabetes. This points out the importance of preventing infections, and if there is a pocket infection, doing the extraction before there are systemic problems from the infection. Discuss the new lead extraction guidelines, entitled Transvenous Lead Extraction: Heart Rhythm Society Expert Consensus Statement on Facilities, Training, Indications and Patient Management, published in May 2009. What were some of the major updates made to the guidelines? The major focus of this new statement on lead extraction is the placement of the focus on total patient management, not just on lead extraction, but on standards for training, personnel and definitions and the need to measure quality and outcomes. Particularly, there is great specificity about the precise indications for lead extraction as well as the need for developing a lead extraction team and for measuring success and complication rates. This is a consensus statement from a large panel of international experts, which was not possible for the prior statement since lead extraction tools and experience were less developed at that time. Explain the proposed lead management registry. Why is it important to create this benchmarking tool? The lead extraction outcomes registry is important to every center involved in this activity because every doctor and patient need to know what to expect for outcomes of the lead extraction procedure. The physician and hospital also need to know how to focus their efforts to maintain quality outcomes. By having a consistent tool, individual centers will be able to compare their local results to generally observed results, and benchmark their outcomes. This is an important principle for all procedures. Also recently published was the Recommendations from the Heart Rhythm Society Task Force on Lead Performance Policies and Guidelines. What key recommendations are included in this document? In 2006 there was a device performance document published that concentrated on monitoring implantable device performance and communicating when there is a potential problem. This new document published in May 2009 specifically focuses on the leads connected to these devices, and tries to provide similar guidance for the leads, which are more vulnerable to failure than the devices themselves. Similar to the device document, detailed discussions and recommendations are made to help physicians, patients, as well as manufacturers and regulatory bodies such as the FDA prevent and monitor for potential problems. Once a problem is detected, then communicating the information in a way that produces the safest result is encouraged. One of the very important recommendations in both documents was that the term ‘recall’ is not the best term to use when a device has a higher failure rate than is appropriate. Strong encouragement is repeated to say that ‘safety alert’ or many other terms would still communicate and yet avoid premature or excessive recommendations to remove a normally functioning device or lead that has a slightly increased rate of failure. Tell us about Spectranetics’ laser sheath (SLS II®). What are some of the benefits of this product? While I cannot endorse one product over another — all of the lead extraction tools have a role and specific circumstances when their use is most helpful — the laser is one of the very important tools. The LExICon data included the laser tool, but was also dependent on the other tools such as locking stylets and various other sheaths and techniques. How has your use of laser-assisted lead removal affected your procedures at the Cleveland Clinic? How many such cases do you handle on average? We have been doing lead extraction since 1988 and laser-assisted lead extraction since 1994. We have averaged about 300 patients and over 500 leads per year for more than the last 10 years. The success of our lead extraction program is based on the training of a large team of people and the support of the hospital system. Having all of the equipment, including laser and many other extraction sheaths and tools, fluoroscopy, anesthesia, as well as collaboration with infectious disease, echocardiographers and surgeons is crucial to consistently effective and safe transvenous lead extraction. How has the practice and management of lead extraction changed over the years? At first, when the tools and techniques were in development, we would change what we did on every case, and there was significant invention for every procedure. Now at this point in time, the tools, techniques, personnel and outcomes are completely predictable. It is this maturation of the lead extraction and patient management scenario that has made the new consensus document possible and so important. What we do at the Cleveland Clinic is not necessarily what happens everywhere, but there is now a worldwide consensus about who, what and how to manage these patients. In what instances is lead extraction still not recommended? There are many times that the risk of lead extraction is too high or the benefits insignificant. This relates to the age and condition of the patient and what the problem is that needs to be addressed. We included contraindications to lead extraction in the document as well. For more information, please see: Wilkoff BL, Love CJ, Byrd CL, et al. Transvenous lead extraction: Heart Rhythm Society Expert consensus on facilities, training, indications, and patient management: this document was endorsed by the American Heart Association (AHA). Heart Rhythm 2009 Jul;6(7):1085-104. Epub 2009 May 22.