7/6/23, 10:48 AM Cardiac implantable electronic device lead removal - UpToDate Official reprint from UpToDate www.uptodate.com 2023 UpToDate, Inc. and/or its affiliates. All Rights Reserved. Cardiac implantable electronic device lead removal : Jay A Montgomery, MD : Jonathan Piccini, MD, MHS, FACC, FAHA, FHRS : Todd F Dardas, MD, MS All topics are updated as new evidence becomes available and our peer review process is complete. Literature review current through: Jun 2023. This topic last updated: Jan 24, 2022. INTRODUCTION Cardiac implantable electronic devices (CIEDs), a term that includes permanent pacemakers (PPMs), implantable cardioverter-defibrillators (ICDs), and cardiac resynchronization therapy (CRT) pacemakers, are used to treat a broad array of cardiac conditions. Occasionally, infection, venous occlusion, mechanical lead failure, or other complications that involve or are caused by a CIED result in the need to remove the entire CIED system or one of its components (eg, leads, pulse generator). CIED lead removal is particularly difficult and can result in fatal complications such as pericardial effusion or tearing of the superior vena cava. Thus, the patient-specific and device-specific risks must be carefully assessed for each proposed CIED removal. This topic will discuss the indications for lead removal, lead removal procedure requirements, outcomes, and potential complications of lead removal. Comprehensive discussions of CIED infection, complications of CIED implantation, and device malfunction are found separately. (See "Infections involving cardiac implantable electronic devices: Epidemiology, microbiology, clinical manifestations, and diagnosis".) (See "Cardiac implantable electronic devices: Long-term complications".) (See "Pacing system malfunction: Evaluation and management".) (See "Cardiac implantable electronic devices: Periprocedural complications".) https://www.uptodate.com/contents/cardiac-implantable-electronic-device-lead-removal/print 1/21 7/6/23, 10:48 AM Cardiac implantable electronic device lead removal - UpToDate DEFINITIONS Standardized definitions related to lead removal have been proposed [1]. Lead removal is a general term that encompasses removal of a CIED lead using any technique, while lead explantation and lead extraction are terms with more specific definitions. Lead explantation Lead explantation is defined as removal of a lead that has been implanted for less than one year via the implant vein using only the tools typically supplied for lead implantation in combination with manual traction. Lead extraction Lead extraction is a more complicated procedure that meets one of the following criteria: The lead is removed with the assistance of specialized equipment (eg, laser sheaths) regardless of the implant duration. (See 'Lead removal procedure' below.) The lead is removed via a site other than the implant vein. The lead being removed has been implanted for more than one year. INDICATIONS The most common indications for lead removal are infection, venous occlusion, mechanical lead failure (often resulting in improper pacemaker function or inappropriate ICD shocks), or recalls related to potential lead malfunction [1-3]. As a result of the complex nature of these cases, recommendations for lead removal apply only to those patients in whom the benefits outweigh the risks when assessed on individual patient factors and operator-specific experience and outcomes [4,5]. Infection Infections, which can result in CIED device and lead removal, can generally grouped into two major categories: CIED-associated endocarditis with bacteremia without an alternative source (particularly Staphylococcus aureus) or bacteremia that persists or recurs despite appropriate antimicrobial therapy. Both situations are associated with challenging management and often require CIED device and lead removal [1,6]. A full discussion of the management of infections involving CIEDs is presented separately. (See "Infections involving cardiac implantable electronic devices: Epidemiology, microbiology, clinical manifestations, and diagnosis" and "Infections involving cardiac implantable electronic devices: Treatment and prevention".) https://www.uptodate.com/contents/cardiac-implantable-electronic-device-lead-removal/print 2/21 7/6/23, 10:48 AM Cardiac implantable electronic device lead removal - UpToDate Venous thrombosis/stenosis Upper extremity venous thrombosis and venous stenosis are not absolute indications for lead removal. However, CIED-related thrombosis or stenosis that causes significant symptoms (eg, superior vena cava [SVC] syndrome, ongoing thromboembolic events) or prevents device upgrade is generally an appropriate circumstance for CIED lead removal. Several clinical studies have revealed that venous stenosis and/or occlusion following endovascular pacing and defibrillator lead placement are common occurrences; in most cases, patients remain asymptomatic and do not require specific therapy [7-9]. However, there are situations in which a thrombosis may cause symptoms: The most concerning, albeit least common, is SVC syndrome. If the patient is to undergo stent deployment as treatment, lead removal should be performed prior to stent placement to avoid entrapment of the lead between the stent and the vessel wall [10-15]. (See "Malignancy-related superior vena cava syndrome", section on 'Patients without life- threatening symptoms'.) Lead removal is recommended in rare cases of clinically significant thromboembolic events caused by a lead that cannot be treated in any other way. The more common circumstance in which venous occlusion would necessitate lead removal is when the occlusion does not allow upgrade of an existing device. Under this circumstance, possible approaches include: Contralateral lead placement and tunneling across the chest, which is not advised in some situations (eg, contralateral atrioventricular fistula/shunt, vascular access port, or prior mastectomy). Ipsilateral venoplasty. Lead removal with specialized tools, such as laser sheath, to allow for regaining/retaining venous access. The approach should be individualized based on the patient's circumstances, the desire to decrease lead burden and/or preserve contralateral venous access, and operator experience. As an example, an older adult patient undergoing upgrade to a cardiac resynchronization therapy device may sometimes be a reasonable candidate for contralateral lead placement and tunneling. By contrast, a younger patient is almost always better served by extraction for ipsilateral implantation, due to the additive risks of having leads indwelling in bilateral subclavian veins with several decades of remaining life. https://www.uptodate.com/contents/cardiac-implantable-electronic-device-lead-removal/print 3/21 7/6/23, 10:48 AM Cardiac implantable electronic device lead removal - UpToDate Leads causing harm Lead removal should be performed in patients with leads that pose an immediate risk to the patient s life. Such situations include cardiac perforation or inadvertent placement of a lead in the arterial system, left atrium, or left ventricle. These scenarios are separate from malfunctioning leads in which require careful consideration of abandonment versus removal. Removal of chronically placed leads from the arterial circulation requires specialized procedural techniques to minimize the risk of cerebral embolization. (See 'Lead upgrade and abandonment' below.) Advisory/recall The decision to remove an apparently normally functioning lead or leads in response to a manufacturer's or regulatory body's warning is complex and includes the use of available data that describe the risk of device failure, the patient's clinical status, and the remaining lifespan [1]. Nonetheless, when the response to an advisory or recall results in lead removal, we can learn from the resulting treatment. Data accumulated following several prominent advisories and recalls of CIED leads have provided valuable information for clinicians: In October 2007, Medtronic suspended distribution of the Sprint Fidelis lead due to growing concerns regarding an abnormally high fracture rate [16]. In a retrospective, multicenter review of 3169 patients with Sprint Fidelis leads, the reported failure rates (failure defined as a sudden rise in impedance or inappropriate shocks) were 5, 11, and 17 percent at three, four, and five years postimplantation, respectively [17]. Predictors of higher risk of lead failure were female sex, axillary or subclavian venous access, and previous lead failure. The clinician response to this has been variable, with some only removing leads that demonstrate malfunction, while others have prophylactically removed the lead even without evidence of malfunction. In December 2011, St. Jude Medical announced that the US Food and Drug Administration (FDA) classified its voluntary medical device advisory letter to clinicians regarding the performance of Riata and Riata ST Silicone Defibrillation Leads as a Class I Recall [18]. The incidence rate of conductor externalization is around 5 per 100 patient-years and is notably higher in 8-French compared with 7-French leads [19]. Externalized leads have a higher rate of electrical failure [20]. The decision to pursue conservative monitoring versus lead extraction in this situation is challenging and multifactorial without any firm evidence to guide the decision. In the cases in which lead extraction was pursued and cable externalization was noted, externalization predicted more complex extraction with more frequent use of laser sheaths (71 versus 55 percent) [21]. https://www.uptodate.com/contents/cardiac-implantable-electronic-device-lead-removal/print 4/21 7/6/23, 10:48 AM Cardiac implantable electronic device lead removal - UpToDate Notably, any Riata or Fidelis leads that remain in service have now been intravascular significantly longer than most of those previously studied. As such, extraction of these leads may be more complex than published reports suggest. Lead upgrade and abandonment The placement of new leads or CIED equipment may require extraction or abandonment of existing leads. Some factors that favor extraction rather than abandonment include: A high likelihood of future intravascular device/lead exchanges (eg, young age) High risk of future lead infection (eg, immunosuppression, history of endocarditis) [22,23] Intravascular crowding (eg, four or more leads in the target vessel or five or more leads in the SVC) Inability to place a new lead regardless of the number of leads Electrical interference between a superfluous lead and new leads [1,4] Shorter dwell time of the superfluous lead (eg, less than two years) [24] CONTRAINDICATIONS In most patients, lead removal is associated with benefits that exceed the potential risks of the procedure. However, there are some relative contraindications to percutaneous transvenous lead removal, which include [4]: Lack of required personnel or equipment. Known anomalous placement of leads through structures other than normal venous and cardiac structures (eg, subclavian artery, aorta, pleura, or mediastinum). Lead placement through a systemic venous atrium or systemic ventricle. Concomitant need to remove epicardial lead components. Large vegetations (eg, larger than 2.5 cm), where open extraction or preemptive use of a suction catheter should be considered [1,25,26]. (See 'Embolism' below.) LEAD REMOVAL PROCEDURE Lead removal generally requires a significant amount of advance preparation [1,3]. Knowledge of the patient's comorbidities, prior invasive/surgical history (eg, prior cardiac surgery or presence of an inferior vena cava filter), and lead characteristics such as lead length, diameter, https://www.uptodate.com/contents/cardiac-implantable-electronic-device-lead-removal/print 5/21 7/6/23, 10:48 AM Cardiac implantable electronic device lead removal - UpToDate dwell time, special fixation mechanism (eg, Medtronic Starfix lead), and adapter information are required. The need for pacemaker support (ie, in a pacemaker-dependent patient) and ongoing device therapy must be assessed. Our approach Extraction of leads is technically more challenging than generator removal and carries a risk of vascular and/or cardiac injury. This risk is largely due to the fibrous connections that develop between the leads and the vascular wall or endocardial surface. As the lead is separated from adhesions to veins and endocardial surfaces, these structures can tear, sometimes resulting in immediate hemodynamic collapse. Our approach is as follows: All patients should undergo preprocedural evaluation, which includes a complete history and physical exam, electrocardiogram (ECG), chest radiograph with posterior-anterior and lateral views, and assessment of device function and pacemaker dependency. If doubt exists as to whether the course and position of the lead(s) are normal, a cardiac-gated computed tomography (CT) scan can be helpful. A detailed review of the risks and benefits should be undertaken with the patient, and shared decision-making is paramount. Due to the risk of endovascular injury, lead extraction procedures should be performed with cardiothoracic surgical backup available. Preprocedural pretransfusion testing (typing and crossmatching) for red blood cells should be routinely performed, and we maintain four units of packed red blood cells within the operating room during the procedure. We routinely obtain femoral vein and artery access to ensure rapid access for fluid volume resuscitation, temporary pacing, and access for emergency stabilization procedures such as superior vena cava (SVC) balloon occlusion and cardiopulmonary bypass. While radial arterial access may substitute for femoral arterial access in some low-risk scenarios, patients with a previous sternotomy should have femoral arterial access due to the risk of mediastinal adhesions that can complicate or prevent rapid sternal entry for cardiopulmonary bypass. There is no specific lead removal technique that can maximize efficacy and minimize risk in every individual patient. The choice depends upon a variety of factors, centered around the risk attributed to the lead itself and the risks associated with the patient's clinical condition. Periprocedural sedation is required, along with local anesthesia at the superficial site. Specific choice of sedation should be based on the relative risk of the extraction. In our practice, most extractions are performed under general anesthesia. We recommend having an echocardiography machine in the operating room, turned on, plugged in, and with a cardiac probe (transthoracic echocardiogram [TTE] or https://www.uptodate.com/contents/cardiac-implantable-electronic-device-lead-removal/print 6/21 7/6/23, 10:48 AM Cardiac implantable electronic device lead removal - UpToDate transesophageal echocardiogram [TEE]) in place for emergency use to rapidly recognize pericardial or pleural effusions. In more complex cases or for those with vegetations, continuous intraprocedural ultrasound imaging (intracardiac echocardiography [ICE] or TEE) can be helpful to guide the procedural strategy [27]. Postprocedural management includes routine postoperative monitoring for hemodynamic changes suggestive of internal complications, as well as observation for bleeding at the pocket or vascular access sites. In addition, a postprocedure chest radiograph is performed to document hardware removal and/or new lead implant. If unexpected hypotension or other signs of internal bleeding or tamponade arises, a TTE is warranted. The duration of postprocedural observation depends on the likelihood of postprocedural complications and the need for ongoing inpatient management (eg, temporary pacing, intravenous antibiotics). Preprocedural evaluation Preprocedural evaluation helps to plan the extraction procedure. The evaluation includes an assessment of the CIED components to be removed (eg, dwell time, anatomic course on radiography) and patient characteristics that may require management prior to extraction (eg, anticoagulation, heart failure). For patients taking long-term anticoagulation therapy, providers will need to discuss the optimal approach to periprocedural management, including risks of bleeding versus thromboembolic risk of interrupting therapy. We instruct almost all patients to discontinue long-term oral anticoagulation therapy to reduce the risk of catastrophic bleeding. Techniques The choice of a specific lead removal technique depends upon a variety of factors, centered around the risk attributed to the lead itself and the risks associated with the patient's clinical condition. There is no single technique that will be most effective in every patient. There are a variety of techniques for lead removal [1,28]: Direct (manual) traction A stylet is inserted into the hollow center of the lead, extending close to the distal electrode, and the helix is typically retracted, if possible. If needed, a stylet designed for lead extraction locks into place, providing support and allowing the application of direct traction to remove the lead. Leads that are isodiametric (the same diameter along the length of the lead) and less than one year old can often be removed by manual traction alone. Significant traction should not be placed on a lead without a locking stylet, as unraveling of the lead makes it impossible to advance a locking stylet. Similarly, a locking stylet or other lead extender is a prerequisite for most other extraction techniques. https://www.uptodate.com/contents/cardiac-implantable-electronic-device-lead-removal/print 7/21 7/6/23, 10:48 AM Cardiac implantable electronic device lead removal - UpToDate Telescoping sheaths Specially designed sheaths extend over the lead, dissecting it away from the vascular wall and endocardium. Complete lead removal success can be as high as 97 percent [29]. Excimer laser sheaths The laser in these sheaths dissolves, rather than tears, the fibrous attachments to the vasculature. Rotational cutting tool sheaths Mechanical sheaths with rotational cutting blades are used to cut fibrous adhesions. Snares A variety of snares inserted via the femoral vein serve as an adjunct to tools utilized from the implant site to allow for lead removal, removal of lead fragments, or to provide additional traction on the lead. Surgical removal Cardiotomy with surgical removal is usually reserved for cases in which transcutaneous approaches have failed or are impossible (epicardial leads). In some patients with large vegetations attached to the lead (eg, >2.5 cm with globular shape), surgical removal may be required in order to minimize the risk of pulmonary embolism (PE), though we currently favor use of a suction catheter as the initial approach. Suction catheters Large vegetations can potentially be removed with suction catheters, which can then allow a safer percutaneous extraction without the need for open cardiac surgery. (See 'Embolism' below.) Factors that increase the likelihood of adhesion formation between endovascular structures and CIED leads include lead placement for more than two years, ICD leads (especially ICD coils located in the SVC), and younger patient age [30-33]. In patients who have any of these features or in whom the lead is suspected to be adherent to an endovascular structure, extraction is performed with specialized techniques and equipment that breaks fibrous adhesions and provides countertraction, which improves the success and safety of the procedure [28,34]. Facility and operator requirements Lead removal is performed under intravenous sedation or general anesthesia in the electrophysiology laboratory or operating room with high-quality fluoroscopy. A complete array of extraction tools as well as surgical instruments should be at hand. The ability to perform TTE and TEE must be immediately available. Because of the potential for serious complications, personnel and resources to perform emergency sternotomy and cardiopulmonary bypass should be immediately available [35]. A multidisciplinary approach involving cardiac surgery, electrophysiology, and cardiac anesthesiology allows for a rapid and successful response to major complications [36]. https://www.uptodate.com/contents/cardiac-implantable-electronic-device-lead-removal/print 8/21 7/6/23, 10:48 AM Cardiac implantable electronic device lead removal - UpToDate Lead extraction should be performed by trained and experienced clinician staff using specialized equipment and only following appropriate patient preparation [1,4]. There is an inverse relationship between complication rates and operator experience [37-40]. Complications have been shown to be 1.5 times more likely to occur during the first 10 cases, with the steepest decline in complication rates during the first 30 cases, and slower but continued decline with further experience, up to 400 cases [39,41]. In a 2014 systematic review and meta-analysis, which included 18,433 patients from 66 observational studies, there was no significant difference in major complication rates depending on center volume [40]. However, a significant inverse association was noted between center volume and rate of minor complications, with centers performing <15 lead extractions annually having significantly higher minor complication rates (7.2 versus 2.1 percent in hospitals performing >30 extractions per year). The informed consent process should include a discussion of the center-specific procedural success and complication rates. (See 'Complications' below.) Outcomes Success rates for lead removal are variable as a result of case selection as well as differences in reporting (ie, complete versus partial removal). Large studies of patients who have undergone lead extraction report relatively high success rates (95 to 99 percent) and low complication rates (<1 percent), although major complications do occur, including cardiac tamponade, vessel laceration, traumatic tricuspid regurgitation (TR), and death [42-51]. However, the likelihood of complications varies with operator experience [28,39,43]. Thus, the results of individual studies, which often reflect the outcomes of experienced operators with high volumes in tertiary/quaternary care centers, are not generalizable to all settings. In the LExICon study, in which 2405 leads in 1449 consecutive patients at 13 centers were extracted via a laser between 2004 and 2007, complete lead removal was reported in 96.5 percent of patients [47]. Procedure failure was higher in leads implanted for greater than 10 years and when performed in low-volume centers. All-cause in-hospital mortality was 1.86 percent and increased to 4.3 percent when lead removal was associated with endocarditis. In 279 procedures involving the removal of 445 leads between 2000 and 2009 at a single center where all leads were removed via manual traction (without the assistance of extraction sheaths), clinical success was approximately 85 percent [52]. This success rate is similar to published data on lead removal using direct traction or telescoping sheaths from a decade prior [53]. The highest clinical success (approximately 95 percent) was observed in patients with leads in place for less than 2.6 years [52]. Comparative data come from a randomized trial of 301 patients with 465 leads in place for an average of 65 to 69 months [45]. Complete lead extraction was achieved significantly https://www.uptodate.com/contents/cardiac-implantable-electronic-device-lead-removal/print 9/21 7/6/23, 10:48 AM Cardiac implantable electronic device lead removal - UpToDate more often using a laser sheath compared with traction through a nonpowered telescoping sheath (94 versus 64 percent). Major complications occurred in 5 of 244 laser lead extractions and in 2 of 221 nonlaser lead extractions. Similar success rates have been reported for the extraction of coronary sinus leads used for cardiac resynchronization therapy. In a single-center, retrospective review of 145 patients undergoing extraction of coronary sinus leads (147 leads total), 99 percent of leads were successfully extracted, 70 percent using manual traction alone [54]. Cardiac tamponade in one patient (0.7 percent) was the only major complication reported. Limited data are available regarding the risks of lead extraction in pediatric patients or adults with congenital heart disease [55,56]. In the international PLEASE registry of 878 patients (mean age 18.6 years) with an ICD implanted between 2005 and 2010, lead extraction was required in 137 patients (involving 143 leads) [55]. All leads were successfully extracted, with major complications, but no deaths, occurring in 6 of 137 patients (4 percent). Complications While CIED lead removal is performed safely in most patients, complications can occur. Most of the complications are traumatic and related to the lead itself (eg, vascular injury, cardiac tear or perforation resulting in cardiac tamponade, TR), although embolization of thrombus or vegetation from the lead is also a concern. When performed by experienced operators, mortality is usually less than 1 percent of patients, with major complications seen in 2 to 4 percent of patients, though risk varies with patient and lead factors [51,57-60]. (See 'Outcomes' above.) In general, ICD leads are more challenging to remove than pacemaker leads as a result of the presence of coils, which tend to be more adherent to vasculature and myocardium. In turn, dual- coil ICD leads are more difficult to remove than single-coil ICD leads. Leads with a passive fixation mechanism may be more difficult to extract than those that are active [42,45]. Lead dwell time is another factor independently associated with adherences, with older leads being more adherent [61]. Additional risk factors for a complication during lead removal include [42,43,62,63]: Pediatric and geriatric age groups Female sex Presence of calcification involving the leads on chest radiograph Presence of multiple leads Death Estimates of mortality following CIED lead removal are highly variable depending on how the variable is defined (eg, procedural mortality, in-hospital mortality, 30-day mortality, etc). https://www.uptodate.com/contents/cardiac-implantable-electronic-device-lead-removal/print 10/21 7/6/23, 10:48 AM Cardiac implantable electronic device lead removal - UpToDate Most published estimates of immediate procedure-related mortality are less than 1 percent, but 30-day mortality is higher, ranging from 2 to 3 percent [51,64,65]. Advancing age, renal failure, device-related infection, and very large (>2 cm) vegetations have been associated with a higher risk of death [65-67]. In a single-center review of 5521 leads extracted during 2999 procedures (mean age 67 years, mean lead implant duration 4.7 years) over a 15-year period (1996 to 2011), 67 patients (2.2 percent) died within 30 days of the procedure [51]. The investigators developed a nomogram incorporating the variable associated with mortality (age, body mass index, hemoglobin, end-stage kidney disease, left ventricular ejection fraction, New York Heart Association functional class, infection, number of previous extractions performed by the operator, and dual-coil ICD leads), and a risk calculator based on the nomogram is available online [68]. In another single-center review of 1006 leads extracted from 510 patients (mean age 64 years, median lead implant duration 47 months) over a 20-year period (1992 to 2012), all- cause mortality was 3.3 percent at 30 days, 7.7 percent at six months, and 10 percent at one year [64]. In a study of 11,304 patients in the NCDR ICD registry who underwent lead extraction (leads in place >1 year) between 2010 and 2012, 258 patients (2.3 percent) had a major complication, among whom 41 (0.36 percent) required urgent cardiac surgery and 14 (0.16 percent) died during the lead extraction [66]. Vascular trauma Though relatively rare, vascular trauma can lead to rapid hemodynamic compromise. Vascular trauma is most likely to occur in patients with multiple or long-standing leads, in particular leads that are adherent to the wall of the SVC or innominate vein, requiring excimer laser or mechanical dilator sheaths to aid in removing the lead [60]. In response to the concern for vascular laceration, specifically SVC tear and its associated morbidity and mortality (approximately 50 percent), an SVC occlusion device received FDA approval in February 2016. Several small series have suggested that the occlusion device can be rapidly deployed and may improve the likelihood of surviving an SVC tear [69,70]. In the largest reported series of 114 cases of confirmed SVC tears identified through search of the FDA database, 51 patients (44 percent) were initially treated with the balloon device; survival to hospital discharge was significantly higher among patients treated with balloon occlusion (88 versus 57 percent in patients without use of the balloon device) [71]. Tricuspid regurgitation Between 5 and 10 percent of patients develop significant traumatic TR following right ventricular lead removal [72-74]. https://www.uptodate.com/contents/cardiac-implantable-electronic-device-lead-removal/print 11/21 7/6/23, 10:48 AM Cardiac implantable electronic device lead removal - UpToDate In a prospective study over a five-year period during which 237 leads were removed from 208 patients using a variety of techniques, traumatic TR occurred in 19 patients (9 percent) and was severe in 14 (7 percent) [72]. Nine of these 14 patients developed new right-sided heart failure. Multivariate analysis identified three independent risk factors for traumatic TR: use of a laser sheath, use of both a laser sheath and snare, and female sex. However, it is possible that laser and snare use identified more complex extractions rather than being causative for TR. In a prospective single-center study in which 266 leads were removed from 208 patients (90 percent with laser extraction) between 2014 and 2016, 24 patients (11.5 percent) developed an acute worsening of TR by TEE assessment, although no long-term follow up data were reported [75]. Embolism In spite of concern that percutaneous lead extraction of large vegetations or thrombus might precipitate PE, clinically relevant acute PE is uncommon even with vegetations >10 mm in size [5,76-81]. However, septic pulmonary emboli are more likely in patients with vegetations >1 cm and are associated with an increased risk of mortality among patients with CIED endocarditis [53,82,83]. In addition, among patients with vegetations >2 cm, a globular shape (rather than linear) is associated with increased mortality [84]. Based upon this data and the high 30-day mortality of patients with CIED endocarditis, we attempt to debulk vegetations that are 1.5 cm or that have a globular shape using suction catheters. Though data from randomized trials are not currently available, the high morbidity and mortality of CIED endocarditis seem to suggest that outcomes may be improved if effective vegetation debulking can be achieved with low procedural risk. Open surgical extraction can be considered in the case of very large vegetations, but we no longer employ this technique due to the availability of suction-catheter systems, which were designed to retrieve thrombi from the vasculature. Observational data suggest that suction- catheter systems are safe and effective at removing vegetations [25,26]. The decision to debulk a vegetation prior to extraction is made on a case-by-case basis [5], but the risk of clinically relevant acute PE was rare in several cohort studies: In a retrospective study of 53 cases of pacemaker-lead endocarditis, 29 patients with 49 leads bearing vegetations with a mean size of 17.8 mm underwent successful transvenous removal using locking stylets and sheaths with no clinically apparent PEs [80]. Pacemaker leads with larger vegetations (mean size 22.4 mm) were removed by open cardiac surgery in 24 patients, three of whom died. https://www.uptodate.com/contents/cardiac-implantable-electronic-device-lead-removal/print 12/21 7/6/23, 10:48 AM Cardiac implantable electronic device lead removal - UpToDate In a single-center study of percutaneous lead removal (215 leads in 100 patients) in the setting of intracardiac vegetations, either on the leads or on the valves and ranging in size from 0.2 to 4.0 cm (mean 1.6 cm) in diameter, embolization of vegetation material, which measured >2 cm before extraction, was witnessed in only two cases with a third case that was presumed to have embolized (97 percent overall success rate for removal without embolization) [82]. In spite of the apparent embolization, all three patients recovered completely. [82] Paradoxical embolization of vegetation or thrombus into the systemic circulation at the time of lead extraction is possible, albeit rare, in patients with a patent foramen ovale (PFO). Among a cohort of 774 patients undergoing transvenous CIED lead extraction in the Mayo Clinic system over 17.5 years, postprocedural stroke occurred in 1 percent of patients and was significantly more likely among patients with PFO and right-to-left shunting [85]. SOCIETY GUIDELINE LINKS Links to society and government-sponsored guidelines from selected countries and regions around the world are provided separately. (See "Society guideline links: Cardiac implantable electronic devices".) SUMMARY AND RECOMMENDATIONS Lead removal is a general term that encompasses removal of a cardiac implantable electronic device (CIED) lead using any technique, while lead explantation and lead extraction are terms with more specific definitions. (See 'Definitions' above.) The most common indications for lead removal are infection, venous occlusion, mechanical lead failure (often resulting in improper pacemaker function or inappropriate implantable cardioverter-defibrillator [ICD] shocks), or advisory or recall as a result of (potential) lead malfunction. As a result of the complex nature of these cases, recommendations for lead extraction apply only to those patients in whom the benefits outweigh the risks when assessed on individual patient factors and operator-specific experience and outcomes. (See 'Indications' above.) Relative contraindications to percutaneous transvenous lead removal include unavailability of required personnel or equipment, the patient not being a candidate for emergency https://www.uptodate.com/contents/cardiac-implantable-electronic-device-lead-removal/print 13/21 7/6/23, 10:48 AM Cardiac implantable electronic device lead removal - UpToDate thoracotomy, or anomalous lead placement. (See 'Contraindications' above.) Lead removal generally requires a significant amount of advance preparation. Knowledge of the patient's comorbidities, prior invasive/surgical history (eg, prior cardiac surgery or presence of an inferior vena cava filter), and lead characteristics such as lead length, diameter, and adapter information are required. The need for pacemaker support (ie, in a pacemaker-dependent patient) and ongoing device therapy must be assessed. Due to the risk of endovascular injury, lead extraction procedures should be performed with cardiothoracic surgical backup available. (See 'Lead removal procedure' above.) On occasion, previously placed leads may be capped and abandoned during CIED upgrade. Abandoned leads, however, pose a risk of interference with the placement or operation of another CIED and may need to be removed. In the absence of contraindications, we suggest removal of abandoned leads at the time of an indicated CIED procedure if implantation of the new device would result in greater than four unilateral leads or greater than five leads through the superior vena cava (Grade 2C). (See 'Lead upgrade and abandonment' above.) There are a variety of techniques and equipment used for lead removal, including direct (manual) traction, locking stylets, nonpowered "mechanical" sheaths, excimer laser powered sheaths, rotational cutting blade sheaths, and endovascular snares. (See 'Techniques' above.) Success rates for lead removal are variable and often reported in terms of complete versus partial removal. Large series of patients who have undergone lead extraction have reported high success rates (95 to 99 percent). Most of the complications are traumatic and related to the lead itself (eg, vascular injury, cardiac perforation resulting in cardiac tamponade, tricuspid regurgitation), although embolization of thrombus or vegetation from the lead is also a concern. When performed by experienced operators, mortality is usually less than 1 percent of patients, with major complications seen in 2 to 4 percent of patients. (See 'Outcomes' above and 'Complications' above.) ACKNOWLEDGMENTS The UpToDate editorial staff acknowledges Brian Olshansky, MD, and Jonathan Weinstock, MD, FACC, FHRS, who contributed to earlier versions of this topic review. Use of UpToDate is subject to the Terms of Use. https://www.uptodate.com/contents/cardiac-implantable-electronic-device-lead-removal/print 14/21 7/6/23, 10:48 AM Cardiac implantable electronic device lead removal - UpToDate REFERENCES 1. 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