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

Abstract

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 rev