Pathways for training and accreditation for transvenous lead extraction: a European Heart Rhythm Association position paper

The European Heart Rhythm Association charged the present writing committee with the task of producing a consensus document on training and accreditation for transvenous extraction of chronically implanted pacing and defibrillator leads.1,2 The core curriculum for the European Heart Rhythm Specialist includes implantation of heart rhythm devices but does not specifically mandate learning and accreditation for extraction techniques.3 The lack of such recommendations is related to the limited number of extractions available for training purposes and attaining competency. The present document focuses on the rising burden and the increasing complexity of techniques of lead extraction with an emphasis on the critical issues of training, accreditation, and documentation of results. There is also an educational component felt necessary to include by the Task Force in view of the specialized and emerging nature of this field. Where appropriate, a European perspective is presented and paediatric aspects are treated separately. The aim is to complement two recently published documents, one from the Heart Rhythm Society (HRS)4 on facilities, training, indications, and management of transvenous lead extraction and the other from the American Heart Association on device-related infections.5 The indications for lead extraction have not changed since these publications and are therefore not covered in this present document. Due to improving recognition of clinical need and wider indications, the implant rate of Cardiovascular Implantable Electronic Devices (CIED) continues to rise in most countries.6,7 The number of leads per patient is increasing with cardiac resynchronisation therapy–pacemaker/defibrillator, upgrades and a higher proportion of dual vs. single-chamber devices. As life expectancy has risen, so have the number of generator and lead changes despite advances in technology. Product advisories are inevitable despite overall improvements in reliability and have led to surges in extraction.8–10 Currently, infection accounts for approximately two-thirds of all extractions.2,11–15 Lead revisions and generator changes carry a greater risk of infection than new implants. Ageing patients are more likely to be immuno-compromised, to have septicaemia16 and to be on anti-thrombotic agents and anticoagulants. These potential risk factors for CIED complication are becoming more prevalent with time along with the risk of hospital acquired infections. The rates of CIED infection are growing out of proportion to the rise in new implants.17 Clinical manifestations of cardiac device infections may be local or systemic, and primary or secondary to septicaemia, particularly with staphylococcus.18–20 Although the majority present as a pocket infection or erosion in the absence of septicaemia,11,19 the intravascular portion of the lead is usually culture positive.5,21 Superficial skin infection overlying but not adherent to the pocket, that responds rapidly to antibiotics, may not require further action. This is in contrast to the treatment needed for pocket infections or erosions. Erosion may be caused by infection or mechanical factors or a combination of the two. Adherence of the generator or leads to the skin often precedes erosion. Most CIED national databases or registries do not detail the number of extractions, may underreport infections and do not identify or separate out erosions. Where data are available on complications and their treatment, the usual estimate is of prevalence using the number of new implants as a denominator. True incidence calculated from the number of complications expressed as a proportion of the time of exposure to the risk, in this case lead exposure, has rarely been calculated.22,23 Local extractions rates will vary on case mix and in-house expertise. Reports from specialized centres are often biased towards more complex systems and include external referrals. The majority of extraction procedures are transvenous and performed by cardiologists and/or cardiac surgeons.2,24 Taking all these considerations and limitations in mind, the Task Force has attempted to calculate the total transvenous extraction need based on 1.5 times the prevalence of reported infection in patients implanted with a CIED (Table 1). This broad approximation holds out the possibility of assessing trends and national differences in extraction requirements. The incidence of both infectious and non-infectious cases appears to be rising. It is assumed that the ratio is stable, but in future, the proportion of extractions that are for non-infectious causes may increase reflecting greater extractor experience and confidence. The prevalence of infection from registries and national databases varies widely but mostly within the range of 1–4%. Estimated need for transvenous lead extraction Estimated need for transvenous lead extraction Details of the criteria of clinical and technical success in lead extraction have recently been reviewed.4 All leads should be extracted if the indication is infection.5 However, residual lead tips or conductor coils, in the absence of insulating materials, rarely prevent full recovery from a CIED infection. A full appreciation of the pathophysiology of CIED implantation is critical to understanding of the risks and the training required for successful lead extraction. At the time of implantation of transvenous leads, trauma may occur to the lead and to the route of passage. Rarely, lead parts may be positioned outside the venous system, either due to migration, or placement via or through abnormal structures. Acute thrombus formation and venous occlusion are not uncommon but it is unusual for this to be evident clinically. Leads may suffer from intrinsic malfunction due to shortcomings in design and production. Such malfunction may exist at implant or develop later.25,26 Despite meticulous preparation of the skin, bacterial contamination of the generator occurs in up to one-half of all implants.27–29 Subsequent clinically relevant infection is uncommon, is more often delayed than acute, and may first become evident years after the implantation.19 During the chronic phase of lead implant, thrombus may organize, leading to subtotal or total occlusion along the venous route, and formation of fibrous bridges or tunnels containing the pacing lead at points of adherence.30,31 The commonest binding sites are located at the venous entry, especially under the clavicle, at the brachiocephalic and/or upper caval vein, the right atrium, by adherence to the tricuspid valve or passage through the papillary muscle network, and finally at the electrode–cardiac interface. Binding may also occur between leads, and is more likely if the surface is irregular, most noticeably with implantable cardioverter defibrillator (ICD) lead coils. The fibrous tissue becomes covered with endothelium and sometimes calcifies. These chronic responses to lead implantation are usually progressive, and occur more readily in younger patients. Beyond :1 year from implantation this process directly affects the complexity and risks of extraction. The Task Force has adopted the definitions as recommended by the HRS4 Lead removal: Removal of a pacing or defibrillator lead using any technique. Lead explant: Lead removal using simple traction techniques from venous entry site (i.e. no locking stylet, telescoping sheath, or femoral extraction tools). Lead extraction: Removal of a lead that has been implanted for >1 year, or a lead regardless of the duration of implant requiring the assistance of specialized equipment that is not included as part of the typical implant package, and/or removal of a lead from a route other than via the implant vein. Implantable cardioverter defibrillator leads may require specialized extraction equipment even when implantation duration is <1 year. Surgical removal, necessary for epicardial leads and also some transvenous leads, is not addressed by this position paper. The main obstacles to extraction are the tissue binding sites along the course of the lead and the interface between the lead tip and endocardium. For most there is more than one binding site, and simple traction of the proximal lead end will not be transmitted to the distal tip. In these circumstances, there is a significant risk of lead disruption and tissue rupture with all the complications that can ensue. A locking stylet within the lumen of the lead spreads the traction forces along the lead body including the tip. The strength and extent of the bridging tissue may still be too great to safely use this tool alone. Other traction devices include snares, sutures, and grasping devices. It is often necessary to use these in conjunction with sheaths designed to directly release bridging tissue. Devices snaring or engaging the lead externally from the femoral or internal jugular route may enable the lead to be routed forwards; this avoids or reduces the risk of catching on bridging tissues. Lead traction: Refers to the pulling force applied on the lead. Sheaths: Sheaths operate with simple mechanical action (non-powered) or additional power and may be used singly or housed within a second sheath to create a telescoping system. Using traction through a sheath enhances safety as well as success. Counterpressure and countertraction: Counterpressure is performed by applying simultaneously a forward pressure on the sheath and traction to the lead. Countertraction is performed when the sheath has been progressed to the lead tip-myocardial surface; the traction applied on the lead is opposed and counterbalanced by pushing pressure of the overlying sheath on the endocardium thereby limiting myocardial invagination or avulsion. Mechanical tip dislodgement is achieved by rotating motions of a non-powered sheath, allowing mechanical dissection of the surrounding fibrosis. Locking and other extraction stylets are designed to stabilize and stiffen the lead and to provide traction near the electrode tip. If simple gentle traction fails to remove the lead a sheath system is employed. Sheaths in combination with a non-locking or a locking stylet enable counterpressure and countertraction causing mechanical dissection, separating the lead from the adjacent tissues. Non-powered sheaths are made of various compounds, including polytetrafluoroethylene, polypropylene, and metal. The aim of powered sheaths is to advance along the lead with reduced traction and counterpressure compared with ‘non-powered’ sheaths. The excimer laser system ablates binding tissue around the circumference of the lead to a depth of 50 μm.32–34 The electrosurgical dissection sheath utilizes radiofrequency energy produced by a standard electrosurgical unit to cut through fibrous tissues.35 The most recent powered sheath, has a cutting screw tip operated by mechanical rotation through a hand held ratchet mounted on the sheath.36 The shorter version of this can be used to gain venous entry, and both are particularly useful when there is fibrous and tissue along the of the lead. are useful for leads are not from the venous entry site of and the venous system, for lead or as first for The usual is a sheath through the femoral and used in conjunction with any number of and grasping A is of this position if the lead is extraction is first attempted by a stylet, a non-locking stylet, to the the if and applying the for most to use a specialized locking If traction is a sheath is the will on the potential of the lead and as well as experience and of the sheath the lead may be by of tissue at the tip. 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