The Lead Extraction Program at the Valley Heart & Vascular Institute: Experience and Review of the Guidelines in Lead Management

Background

The number of cardiac implantable electronic device (CIEDs) implants has climbed steadily, due to expanding indications for both arrhythmia treatment and an aging population. Although CIEDs provide a wide array of lifesaving and quality of life-enhancing therapies, they are also mechanical devices and foreign bodies prone to failure and infection. In addition, they can sometimes lead to venous occlusion, making placement of new leads difficult. The imperative to address these issues, as well as challenges related to vein patency and MRI compatibility, has resulted in a need to manage leads using a number of methods.¹

Lead extraction technology has grown considerably over the past two decades from simple manual extraction maneuvers to the use of powered, telescoping sheaths equipped with laser technology. An estimated 10,000–15,000 pacemaker and implantable cardioverter-defibrillator (ICD) leads are extracted annually worldwide.² Data from single-center experiences and randomized controlled trials have continued to demonstrate the safety and efficacy of current lead extraction technology. Still, major complications occur in less than 1% of patients.³ 

Patient preparation and in-place laboratory protocols are important for the prevention of, as well as the rapid diagnosis and treatment of, life-threatening complications should they arise. Lead management decisions require an understanding of lead design and the pathophysiology of mechanical and clinical issues associated with lead dysfunction. Ultimately, management of the patient and the CIED system relates to a balance of the risks of each therapeutic option. 

Lead Extraction Guidelines

In May 2009, the Heart Rhythm Society (HRS) updated its expert consensus recommendations for transvenous lead extraction.⁴ Based on these guidelines, the indications for lead extraction can be divided into several succinct categories: infection, malfunction, upgrade (abandoned/unused lead), venous occlusion/stenosis, and safety alerts. Currently, infection accounts for approximately two-thirds of all extractions worldwide.^5-7

The safety and efficacy of transvenous lead extraction varies widely, and the number of trained physicians lags behind the current demand for this procedure. Despite technological advances, lead extraction still has the potential for significant morbidity and mortality. Complication rates with lead extraction directly parallel operator experience. The HRS guidelines specify that lead extraction should only be performed by physicians well trained in the technique, at institutions with properly trained staff, and when a cardiac surgeon is immediately available who is well informed about the complications and management of the injuries that could result from extraction. Analysis of lead extraction outcomes suggests that the frequency of complete procedural success improves dramatically after the first 10–20 procedures have been performed. Even experienced physicians have a reduced frequency of complete procedural success when 60 or fewer laser-assisted lead extraction procedures were accomplished over the prior 4 years. As far as volume requirements, the current HRS guidelines state that physicians being trained in this technique should extract a minimum of 40 leads as the primary operator under the direct supervision of a qualified training physician. Physicians who have already extracted over 40 leads as a primary operator should maintain a minimum volume of 20 leads extracted annually to meet training and volume requirements. 

Lead extraction volume varies greatly even among experienced centers. In a recent survey of lead extractions performed in the U.S., most respondents reported low annual volumes of extractions at their site: 15% reported <10 procedures/year, 42% reported 10–25 procedures/year, 23% reported 26–50 procedures/year, and only 19% reported >50 procedures/year.⁸

Experience at The Valley Hospital

The Lead Extraction Program at Valley was established in 2006. Along with Dr. Suneet Mittal, Director of the Electrophysiology Lab and Dr. Mark Preminger, Director of the Implantable Device Section, we form a group of highly trained and experienced individuals in the field of transvenous lead extraction techniques (Figures 1 and 2). This group of physicians serves as mentors for lead extraction in collaboration with professional societies and industry. We have hosted and collaborated on a number of educational conferences addressing contemporary lead management techniques. Dr. Mittal has presented on product safety, remote monitoring technology, and lead extractions; he was also an invited speaker at the arrhythmia symposia, discussing the role of lead extractions in clinical practice and management of Fidelis leads. Dr. Preminger has presented on product safety and lead extractions. I also presented on product safety, on multi-disciplinary approaches to managing patients with an infected cardiac device, and on laser extraction considerations with reference to location, equipment and personnel at the 2012 annual Heart Rhythm Society scientific sessions. 

We have also previously contributed and shared data with other large extraction centers. We  recently collaborated on a research correspondence published in the Journal of American College of Cardiology entitled “Superior Vena Cava Defibrillator Coils Make Transvenous Lead Extraction More Challenging and Riskier.”⁹ This was a retrospective analysis of patient and lead characteristics, procedural outcomes, and complications of consecutive patients undergoing ICD lead extraction at 9 high-volume centers. Between January 2000 and February 2011, a total of 2,201 patients underwent extraction of 2,274 ICD leads. Eighteen major complications were observed, all in cases involving dual coil ICD leads. Difficulty of lead extraction was significantly associated with the presence of an SVC coil. We concluded the presence of an SVC coil was associated with significantly higher complication rates and lead extraction of dual coil ICD leads was 2.6 times more difficult as compared with single coil ICD leads. 

As extracters, we think carefully about all implants and only implant what is absolutely necessary. Given the known lack of benefit of dual coil ICD leads in the vast majority of patients and the associated extraction risks, routine implantation of dual coil ICD leads is not performed at our institution. The vast majority of implants are single chamber ICDs. Valley is also one of only 2 centers in the NY/NJ area to have access to S-ICD (subcutaneous-ICD) technology, which when used appropriately, has the potential to make lead extraction issues obsolete.

At our institution, patients can be treated effectively with high clinical extraction success rates and <1% major complication rates, which are at par with other experienced extraction centers. Our group performs more than 50 extractions a year.

According to the most recently published HRS guidelines, lead extraction is appropriate in patients with infection or bacteremia, chronic pain, functional leads that due to design or failure pose potential threats or need to be abandoned, non-functional leads that interfere with the operation of implantable devices or need to be abandoned, venous occlusion, MRI requirements, and device upgrades. These are the indications for which patients are referred to us for a lead extraction procedure at Valley Hospital.

After a full consultation, after which patients are identified as appropriate candidates for lead extraction, we perform routine perioperative lab testing and review medications in order to bridge or discontinue anticoagulants in the perioperative period. In accordance with the HRS guidelines, we perform most of our lead extractions in the OR with surgical backup. We use high-quality fluoroscopy in the OR, and all of our patients are intubated and monitored during the procedure by a cardiac anesthesiologist. Transesophageal echocardiography is performed at the beginning of the procedure and additional surveillance is performed throughout the procedure. We have access to basic and advanced extraction tools as well as a femoral workstation. We have a variety of extraction sheaths, including powered and mechanical telescoping steel and polypropylene sheaths. Stylets, wrenches, fixation tools, repair kits, adapters, sterile sleeves for the programmer, pin plugs, lead anchoring sleeves, and lead end caps as well as wire cutters and locking stylets are available. Femoral workstation and a variety of snares and angiographic guide catheters are included in the extraction armamentarium in case a superior approach is unsuccessful at complete extraction and a femoral approach needs to be utilized. During the procedure, one physician is identified as the primary operator and has an assistant physician or technician scrubbed to assist. A backup surgeon is contacted before and as the case starts/ends. Along with the cardiac anesthesiologist, there are at least two non-scrubbed assistants (nurse, technician) and a fluoroscopy operator. After the procedure, most patients are extubated in the OR, monitored in the PACU and an intensive care unit for 12 hours, and discharged the following morning.

We fully recognize that patient preparation and laboratory protocols are critical for the prevention, rapid diagnosis, and treatment of life-threatening complications. Direct preparation of the patient for lead extraction includes the availability of baseline blood tests (metabolic profile, CBC and coagulation profile) and blood that has been typed and cross-matched. For most procedures, at least 4 units should be available, while for some “high-risk procedures some blood should be in the procedure room.” Obtaining large bore (18 gauge or larger) venous access is required, and femoral venous access is strongly encouraged since it provides venous access, facilitates temporary pacing, and provides a femoral access route for extraction and delivery of fluids, blood and drugs in the advent of a vascular emergency. The patient will require continuous electrocardiographic and blood pressure monitoring. Though the blood pressure may be monitored using noninvasive methods, invasive monitoring provides faster recognition of changes and is preferred by most experts. The patient’s skin should be prepared with antiseptic solution in such a manner as to allow for an emergent pericardiocentesis, thoracotomy, sternotomy and cardiopulmonary bypass. The ability to perform transcutaneous pacing and defibrillation using preapplied adhesive pads is essential. In addition, we perform transesophageal echo for additional imaging of the heart and valvular apparatus during the procedure. Equally important to the success of an extraction program is a team approach and advanced multidisciplinary planning. Our surgical colleagues are in an adjacent OR at the time of the majority of our extraction procedures.

Success in lead extraction procedures requires a commitment to continuous quality improvement. A commitment to clinical outcome measurement is also fundamental to the performance of transvenous lead extraction, in part because it is essential to an accurate informed consent process. Only when the risks of both doing and not doing the procedure are accurately understood by both the physician and the patient can an appropriate informed decision be made. We feel based on our experience that the lead extraction procedure can be performed with equivalent safety in academic and community centers when there is commitment to volume requirements, quality and infrastructure. Ultimately, it is access to timely intervention that will lead to improved patient outcomes.

The Valley Hospital, a 451-bed, acute care, not-for-profit hospital located in Ridgewood, New Jersey, is part of Valley Health System, which also includes Valley Home Care and Valley Medical Group. Valley is an affiliate of the New York-Presbyterian Healthcare System and the recipient of numerous awards and recognitions. These include 10 consecutive recognitions for service excellence by J.D. Power and Associates for inpatient care, and two major awards for patient safety and quality care from the Leapfrog Group, which ranked Valley among the top hospitals in the nation. Valley is ranked No. 1 in New Jersey by Healthgrades for overall cardiac services, cardiac surgery, and coronary interventional procedures.

Disclosure: Dr. Arshad has no conflicts of interest to report regarding the content herein. Outside the submitted work, Dr. Arshad reports consultancy and honoraria with Medtronic, and travel accomodation expenses covered or reimbursed by Boston Scientific.  

References

1. Love CJ. Update on indications, techniques, and complications of cardiac implantable device lead extraction. Curr Treat Options in Cardiovasc Med. 2012;14:565-570.
2. Hauser RG, Katsiyiannis WT, Gornick CC, Almquist AK, Kallinen LM. Deaths and cardiovascular injuries due to device assisted implantable cardioverter–defibrillator and pacemaker lead extraction. Europace. 2010;12:395-401.
3. Neuzil P, Taborsky M, Rezek Z, et al. Pacemaker and ICD lead extraction with electrosurgical dissection sheaths and standard transvenous extraction systems: results of a randomized trial. Europace. 2007;9:98-104.
4. Wilkoff BL, Love CJ, Byrd CL, et al. Transvenous lead extraction: Heart Rhythm Society expert consensus on facilities, training, indications, and patient management. Heart Rhythm. 2009;6:1085-1094.
5. Sohail MR, Uslan DZ, Khan AH, et al. Management and outcome of permanent pacemaker and implantable cardioverter-defibrillator infections. J Am Coll Cardiol. 2007;49:1851-1859.
6. Uslan DZ, Dowsley TF, Sohail MR, et al. Cardiovascular implantable electronic device infection in patients with Staphylococcus aureus bacteremia. Pacing Clin Electrophysiol. 2010;33:407-413.
7. Maytin M. Simulation Training Efficacy to improve Extraction Performance (STEEP). HRS 2013.
8. Henrikson CA, Zhang K, Brinker JA. A survey of the practice of lead extraction in the United States. Pacing Clin Electrophysiol. 2010;33:721-726.
9. Epstein LM, Love CJ, Wilkoff BL, et al. Superior Vena Cava Defibrillator Coils Make Transvenous Lead Extraction More Challenging and Riskier. J Am Coll Cardiol. 2013;61:987-989.