2018 EHRA expert consensus statement on lead extraction: recommendations on definitions, endpoints, research trial design, and data collection requirements for clinical scientific studies and registries: endorsed by APHRS/HRS/LAHRS
The number of cardiac implantable electronic device (CIED) implantations has increased over recent years1,2 as a result of population growth, increasing life expectancy, adoption of guidelines, and better access to healthcare. Transvenous lead extraction (TLE), as a part of an overall lead management strategy, has also been increasing, not only as a consequence of this growth, but also because of increasing rates of infection,3 lead failure, awareness of indications for lead management, and development of extraction tools. Clinical research is essential for understanding efficacy and risks of TLE, which has important implications regarding decision-making and therapeutic strategies in patients who are candidates for this procedure. Data on TLE have mainly come from retrospective series, with variable reporting of endpoints. Recently, the ELECTRa registry conducted by the European Heart Rhythm Association (EHRA), has reported the largest prospective experience on lead extraction published to date in 3555 patients recruited from 19 European countries.4 There remain unresolved issues, which is a strong incentive for conducting further specifically-designed clinical trials to answer important questions in this area. In addition to clinical studies, national registries are potentially useful for evaluating epidemiology of TLE as well as for quality control and understanding resource implications. Standardization of definitions and reporting of parameters are paramount in order to analyse, compare, and pool data for scientific purposes. Expert consensus statements on lead extraction have been published by the Heart Rhythm Society (HRS) in 20095 and 2017,6 and by EHRA in 2012.7 Experience from the ELECTRa registry has been valuable for identifying challenges faced with conducting scientific studies in this field, and provides a framework for future endeavours. This writing group has been commissioned by EHRA to provide recommendations for designing scientific studies, reports and registries relating to lead extraction. In order to clarify the indications for lead extraction the following definitions are proposed (see Table 1). CIED-related infection types CIED, cardiac implantable electronic device. This was the most frequent indication for TLE in the ELECTRa registry amounting to 52.8% (of which approximately two-thirds were local infections).4 Several entities exist, which should be specified. This is defined as an infection limited to the generator pocket or along the lead course. It is clinically associated with local signs of inflammation, including erythema, warmth, fluctuance, wound dehiscence, tenderness, or purulent drainage, with negative blood cultures.8–10 This entity should be differentiated from superficial incisional Infection, which involves only skin and subcutaneous tissue without communication with the pocket (and may not require lead extraction). This is a chronic process whereby the device and/or lead(s) are exposed through the skin, with or without local signs of infection (the device should however be considered infected, whatever the mechanism for erosion). Very often the erosion is preceded by the adherence of the skin on the device with a concomitant browning and thinning of the skin. Erosion is usually indicative of infection. Blood cultures are negative, and some of these patients are asymptomatic, while others complain of local pain. In presence of positive blood cultures with or without systemic infection symptoms and signs. Local signs of pocket infection and positive blood cultures and lead or valvular vegetation(s). The 2015 European Society of Cardiology (ESC) modified Duke Criteria8 have been used to define endocarditis. It should be noted that these criteria are used to define valvular endocarditis. For CIED-related endocarditis, additional criteria might be considered, such as positive cultures of the extracted lead in case of negative blood cultures, presence of lead vegetations, and abnormal metabolic activity around the CIED generator and/or leads detected by 18F-fluorodeoxyglucose (FDG) positron emission tomography (PET)/computed tomography (CT) or radiolabelled leucocytes single-photon-emission computed tomography/CT. Local signs of pocket infection and positive blood cultures, without lead or valvular vegetation(s). Bacteraemia with or without lead or valvular vegetation(s), and without local signs of pocket infection. Bacteraemia without an obvious source other than the CIED. After extraction, disappearance of bacteraemia is expected. In case of lead dysfunction, there is the option of abandoning the lead or extracting it (e.g. to reduce intravascular lead burden or regain access in the presence of venous occlusion). Lead dysfunction was the second most frequent reason for lead extraction in the ELECTRa registry, amounting to 38.1% of cases.4 Causes for lead dysfunction may be lead fracture or insulation failure resulting in issues with lead impedance, sensing or capture. In some cases, the electrical parameters may still be normal, but the integrity of the lead is clearly compromised (e.g. inside out cable externalization of Riata leads, radiological evidence of subclavian crush etc.). There are a variety of situations where a functional lead may no longer be required, with the option of either abandoning or extracting the lead. Examples are upgrades from a pacemaker to an implantable cardioverter-defibrillator (ICD), downgrading from dual- to single-chamber systems, lead recall with prophylactic revision, system relocation for radiotherapy, lack of device indication etc. These abandoned leads may be extracted to reduce the intravascular lead burden in order to avoid future issues (see Table 2). Definitions of terms for non-infected leads CIED, cardiac implantable electronic device. Leads may be functional but cause complications for which extraction may be indicated (e.g. thromboembolic events, superior vena cava syndrome, arrhythmias, perforation, lead-lead interaction etc.). If stenting is planned for treating stenosis in a vein with a transvenous lead, extraction is usually performed to avoid entrapment of the lead. Up to 25% of patients with transvenous leads develop some degree of stenosis,11 which may later hinder additional lead implantation (e.g. in case of upgrades). There are a number of different management strategies,12 which include tunnelling a contra-lateral lead across the chest, venoplasty, or lead extraction to provide a channel through which new leads can be implanted. There is evidence that magnetic resonance imaging (MRI) can be safely performed in patients implanted with non-conditional CIEDs, but abandoned or dysfunctional leads are considered to be contra-indications (even if an MRI-conditional device is implanted).13 Therefore, extraction of these leads may be performed in selected cases, with appropriate assessment of the risk and benefits of the lead extraction procedure, in order to allow access to MRI, when no other diagnostic alternatives to MRI are available. Some patients may have severe chronic pain attributed to lead insertion (e.g. due to a periosteal reaction), for which lead extraction may be performed. It is important to recognize that chronic pain may be a sign of an infection. A number of other rare indications for lead extraction exist, such as prophylactic extraction of leads that due to their design or their failure pose a potential future threat to the patient if left in place e.g. Accufix leads (Telectronics). Lead removal often includes a wide spectrum of tools and techniques, ranging from simple manual traction to multiple procedures and combined approaches (see Table 3). Definition of LE approaches, techniques and tools LE, lead extraction; RFA, radiofrequency ablation. Most lead extractions are performed using a percutaneous approach as it is less invasive. In specific situations (e.g. high-risk procedures or in case of very large vegetations), an open extraction with sternotomy and cardiopulmonary bypass may be preferred. Some centres perform hybrid approaches that combine percutaneous extraction with minimally invasive surgery or thoracoscopy. The various approaches for percutaneous TLE are detailed below. Most lead extraction procedures begin via the identical route of lead implantation, also known as venous entry or implant vein approaches. If the venous entry approach fails, or in the presence of free-floating leads, an internal jugular venous approach can be used, combining superior and femoral accesses.14 Extraction may be performed with femoral venous access as a primary strategy or as a bailout procedure, using specialized tools.15 When reporting data for lead extraction procedures, it is important to be specific regarding the tools and techniques used, as these will have a direct impact on outcome and also on costs. Often, a ‘stepwise’ approach is used whereby the operator transitions from simple to more complex strategies. Therefore, different tools and techniques may be used during a procedure, even for the same lead. In case of a stepwise approach, it is useful to report the sequence of techniques, which were employed for a given lead. Applying mild pulling force without the use of specialized tools (other than a standard stylet) was used in 27% of patients in the ELECTRa registry,4 and may be effective for leads with a short dwell time (i.e. time since implant <1–2 years). These are designed to improve tensile strength to facilitate traction and to stabilize leads. They may be used alone or in combination with other tools such as sheaths. These sheaths are designed for blunt dissection of fibrotic binding sites, using simple manual pushing/rotational force. They are most often composed of polypropylene, but metallic or Teflon (PTFE) sheaths are also available. They may be used alone or with handles that facilitate rotation, and most often with a locking stylet. When reporting use of powered sheaths, it is important to specify which type of tool was used, as their mechanism, efficacy and risk profiles may differ. They are used in conjunction with a locking stylet inserted into the lead, which builds a rail upon which the device is advanced. Rotational mechanical sheaths are currently hand powered and have a threaded tip which dissects adherent tissue.16,Electrosurgical sheaths use radiofrequency energy to dissect fibrous tissue but are now seldom used. Laser sheaths use laser energy delivered circumferentially along the tip of the sheath.17 As additional tools become available this list should be expanded accordingly. These are most often deployed via a femoral approach, and may consist of a single or double15 loop, which can be used for grasping free-floating lead extremities or the lead body (double loop design). These devices are usually introduced via a femoral approach to grasp free-floating lead extremities, but are seldom used today. These wires are used for grasping conductor cables or lumenless leads in order to be able to use an extraction sheath. These tools allow secure binding of locking stylets and the proximal components of the lead to facilitate extraction.18 In case of a vascular tear, these highly compliant balloons are filled with diluted contrast agents to stem bleeding while awaiting surgical bailout.19 Tools that are dedicated to other procedures may sometimes be used for lead extraction (e.g. for grasping leads), such as pigtail catheters, deflectable wires, deflectable catheters, bioptomes, deflectable sheaths etc. It is recommended to report the size of the tools used, as these may impact complications (e.g. bleeding at the venous entry site, collateral damage, etc.). However, it is important to realize that tool size may be labelled differently (e.g. mechanical sheath size usually refers to internal diameters, whereas laser sheath size refers to external diameter), and that use of outer sheaths will also impact tool size. To interpret studies, whether prospective randomized trials or retrospective studies, there must be clear and consistent definitions. Since many complications may occur after the patient leaves the procedural venue, appropriate follow-up should be performed. In addition, true informed consent requires each operator to know their own volumes and outcomes. This requires tracking and able to report in a Definitions of a lead extraction, procedural and complications have been well in the and consensus on and used in the ELECTRa It will be the of this to with to the of A of the that the of lead extraction has which reporting of the and efficacy of lead extraction procedures to The removal of a lead is clearly different from a lead. To the clear definitions for and is not a lead extraction procedure, which have been in the and also in this When a the following definitions should be of a lead or lead using This entity includes removal of subcutaneous leads. A lead removal using simple traction techniques locking sheaths, or femoral extraction and leads were implanted with removal of at lead that has been implanted for more than or a lead of of implant the of specialized that is not as part of the implant and/or removal of a lead from a route other than the implant removal of may be considered as extraction For scientific it is important to of the as a as well as to data on of extraction of leads (e.g. in order to for leads, and for The of will very upon and can only be in case the follow-up is In case of leads, a CIED removal is even if a may be to consensus of In case of non-infected leads, clinical may be of lead tip on A list of definitions regarding and outcome is reported in Table Definitions for extraction procedures and implantable of leads and with the of or where there is by the number of of a of a lead that not impact the outcome of the procedure. This may be the tip or a part of the lead or the when the part not the risk of perforation, events, of or cause of or where there is clinical by the number of to either procedural or clinical or the development of or Extraction procedures that by the number of Lead or extraction with removal of lead Lead or extraction where part of the lead in the body or of complications is more complex as patients may also be additional procedures at the time of extraction, such as (e.g. was the pocket due to the extraction or the In addition, can impact (e.g. the patient as a of the extraction or due to the that was the indication for the It is important that be reported as as to avoid The of the is less important to the patient than the the complications must be and list of complications is in Table clear definitions to and allow for a understanding of the risks of the procedure. 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Some of the are below. in case of devices a removal is the following have to be the of additional diagnostic tools in patients with Clinical of different strategies of and of and their a system to the risk of complications associated with percutaneous removal that will a of patients for an open surgical approach for CIED extraction is the of device with or device as management in local and systemic infection. of of whether open surgery is in patients with a and endocarditis, but without an or other indication for open surgery (e.g. is a size to be extracted by TLE, open surgical or pacemaker and leads a decision-making process when extraction. The issues are around clearly the risk associated with lead and whether the potential of lead extraction the risk of the procedure. 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A further with lack of evidence is the impact of type local with or without on during Data from the ELECTRa registry an even types the centres with a use of local on TLE procedures not clearly specific but require in case the is not performed data to be and to clarify this There a strong to a scientific for lead extraction recommendations in patient patient consist but are not to very and patients potentially open extraction procedures (e.g. lead than or leads into or to these patient is the that the of such patients in single series, even in are to It is of to perform future studies on a data of multiple either in the of studies or a lead extraction registry pool but this is to in the In this a of data should be to allow for data multiple As lead extraction is a for a randomized clinical but questions the should and provide appropriate have published clinical on TLE and large which are to improve understanding in this However, many questions still remain regarding TLE, not only the limited number of randomized trials but also the lack of in reporting procedures and These unresolved issues have given a strong incentive for this consensus The recommendations are to and and are to clinical scientific guidelines, quality and The also in evidence lead extraction, with the to in scientific trials and is available at of The EHRA